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Already published in the CONNEX Report Series:
Volume 1:
Michael Marsh, Slava Mikhaylov and Hermann Schmitt (Eds.):
”European Elections after Eastern Enlargement - Preliminary Results from the European Election Study 2004”
The CONNEX Report Series Nr 1 Mannheim, Germany, January 2007 ISSN 1864-1539 / 1
Volume 2:
Claes de Vreese and Hermann Schmitt (Eds.):
”A European Public Sphere – How much of it do we have and how much do we need?”
The CONNEX Report Series Nr 2 Mannheim, Germany, July 2007 ISSN 1864-1539 / 2
Volume 3:
Morten Egeberg (Ed.)
”Institutional Dynamics and the Transformation of Executive Politics in Europe
The CONNEX Report Series Nr 3 Mannheim, Germany, December 2007 ISSN 1864-1539 / 3
Volume 4:
Michael Marsh and Hermann Schmitt (Eds.)
”The Multilevel Electoral System of the EU”
The CONNEX Report Series Nr 4 Mannheim, Germany, February 2008 ISSN 1864-1539 / 4 Volume5:
Beate Kohler-Koch, Dirk de Bièvre and William Maloney (Eds.)
”Opening EU-Governance to Civil Society – Gains and Challenges”
The CONNEX Report Series Nr 5 Mannheim, Germany, February 2008 ISSN 1864-1539 / 5 online: http://www.connex-network.org/series
European Risk Governance
Its Science, its Inclusiveness
and its Effectiveness
Ellen Vos (ed.) CONNEX Report Series Nr 06 ISSN 1864-1539 / 6 Online: http://www.connex-network.org/series Copyright © by the authors, CONNEX 2008 CONNEX – Network of Excellence University of Mannheim Mannheim Centre for European Social Research (MZES) 68131 Mannheim, Germany Tel: ++49 621 181 2840 Fax: ++49 621 181 2845 http://www.connex-network.org http://www.mzes.uni-mannheim.de
Mannheim, February 2008 Cover, Layout & Typo by: Thomas Schneider, Oliver Schommer (MZES)
Cover picture: Dieter Tyspe 1971/72
II
Editor
Ellen Vos is Professor of European Union Law at the Law Faculty of
Maastricht University. She is member of the Editorial Board of the Maastricht
Journal of European and Comparative Law and of the Editorial Board of the
Maastricht Working Papers on Law and the Ius Commune Book Series.
Ellen Vos has published extensively in the field of EU Law, institutional law
(comitology and agencies), governance, market integration and risk
regulation. (e.vos@ir.unimaas.nl)
Table of Contents List of Abbreviations V Foreword and Acknowledgements Ellen Vos…………………………………………………………. 1 Section 1: European Risk Governance, its Science and its Inclusiveness
Chapter 1 European Risk Governance in a Global Context Michelle Everson and Ellen Vos ……...…………………...……….. 7 Chapter 2 EU Risk Regulation and Science: The Role of Experts in Decision-making and Judicial Review
Alberto Alemanno.......................................................................... 37 Chapter 3 Some Suggestions for a Structured Approach to Participation in Food Risk Governance with a Special Emphasis on the Assessment-Management Interface
Marion Dreyer and Ortwin Renn..................................................... 89 Chapter 4 Innovative Approaches to Stakeholder Involvement in Risk Governance. Lessons from TRUSTNET IN ACTION European Research Project.
Gilles Hériard Dubreuil and Stéphane Baudé..................................... 123 Chapter 5 A Europe of Lay People: A Critical Assessment of the First EU Citizens Conferences
Laurie Boussaguet and Renaud Dehousse.......................................... 153 Chapter 6 The EU Chemicals Policy: Towards Inclusive Governance? Veerle Heyvaert............................................................................. 185
IV
Section 2: European Risk Governance and its Effectiveness
Chapter 7 The Public-private Regulation of Food Safety through HACCP: What does it mean for the Governance Capacity of Public and Private Actors?
Frank Wendler …………………………………………………… 223 Chapter 8 Inspecting Aviation Safety in the EU: EASA as an Administrative Innovation?
Adriaan Schout.............................................................................. 257
List of Abbreviations
AFSSA Agence Française de Sécurité Sanitaire des Aliments (French
Food Safety Agency) BDH Bundesvereinigung Deutscher Handelsverbände e.V.
(German Federation of Retailer Associations) BR Basic Regulation BRC British Retail Consortium BSE Bovine Spongiform Encephalopathy CCs Citizens’ Conferences CCP Critical Control Points CEVA Ceva Santé Animale CFI Court of First Instance CIAA Confédération des Industries Agro-Alimentaires de l’UE (Confederation of Food and Drink Industries of the EU) CIES Comité International d’Entreprises à Succursales
(International Committee of Food Retail Chains) CLIC Comité Local d’Information et de Concertation (Local
Committees for Information and Dialogue) CMRs Carcinogenic, Mutagenic and Reprotoxic Chemicals COM European Commission CPMB Committee for Proprietary Medicinal Products CPVO Community Plant Variety Office CRA Committee for Risk Assessment CSEA Committee for Socio-Economic Analysis DG SANCO Directorate General for Health and Consumer Protection DNEL Derived No-Effect Levels
VI List of Abbreviations
EASA European Aviation Safety Agency EC European Commission EC European Community ECB European Central Bank ECB European Chemicals Bureau ECHA European Chemicals Agency ECJ European Court of Justice ECOSA European Consumer Safety Association ECR European Court Reports ECSC European Coal and Steel Community EEA European Environmental Agency EEC European Economic Communities EFSA European Food Safety Authority EFTA European Free Trade Association EINECS European Inventory of Existing Chemical Substances EMEA European Medicines Agency EMSA European Maritime Safety Agency ENDS Environmental Data Services Ltd EP European Parliament EP ENV Environment Committee of the European Parliament ERA European Railway Agency EU European Union FAO Food and Agriculture Organisation FDA Food and Drug Administration FP Framework Programme FPA Food Products Association FSA Food Standards Agency GFL General Food Law GFSI Global Food Safety Initiative GM Genetically Modified GMO Genetically Modified Organism HACCP Hazard Analysis and Critical Control Point ICAO International Civil Aviation Organisation IFS International Food Standard IGO Inter-governmental Organisation ILO International Labour Organization IPHB Institution Patrimoniale du Haut-Béarn (Patrimonial
Institution of the Haut Béarn) ISO International Standardization Organization
List of Abbreviations VII
JAA Joint Aviation Authority JRC Joint Research Centre MEP Member of the European Parliament NAAs National Aviation Authorities NAFTA North American Free Trade Agreement NASA National Aeronautics and Space Administration NGO Non-governmental Organisation NRA National Regulatory Authority NRC National Research Council OGM Organisme Génétiquement Modifié (Genetically Modified
Organism) OJ Official Journal OLAF Office pour la Lutte Anti Fraud (European Anti-Fraud
Office) PNEC Predicted No-Effect Concentrations PPP Public-Private Partnership PTA Participatory Technology Assessment PTBs Persistent, Toxic, Bioaccumulative Substances QMV Qualified Majority Voting REACH Registration, Evaluation, Authorisation and Restriction of
Chemicals RAISE Recognition of the Achievements of Women In Science,
Medicine, and Engineering RPWS Regulatory Procedure With Scrutiny SCCP Scientific Committees on Consumer Products SCENIHR Scientific Committee on emerging and Newly Identified
Health Risks SCHER Scientific Committee on Health and Environmental SEA Socio-economic Analysis SH2 Securing Health Together SPS Sanitary and Phytosanitary Measures SSC Scientific Steering Committee STOA Scientific and Technical Options Assessment TBT Technical Barriers to Trade TIA TRUSTNET in Action TPCs Third-Party Certifiers
VIII List of Abbreviations
TSE Transmissible Spongiform Encephalopathies UK United Kingdom UNCITRAL United Nations Commission on International Trade Law US United States vPvBs very Persistent and very Bioaccumulative Substances VWA Voedsel en Waren Autoriteit (Dutch Food and Consumer
Product Safety Authority) WHO World Health Organisation WTO World Trade Organisation WWF World Wide Fund for Nature
Foreword and Acknowledgements
Ellen Vos
The question of how public authorities should deal with risks and
uncertainties has become a dominant concern in the wake of the 1992-
programme on the creation of the internal market. CONNEX Research
Group 6, The Transformation of the European Policy Space, co-ordinated by
Renaud Dehousse, thus provides a critical assessment of the devices that have
been established to ensure cooperation between the national and the
European level in various areas. It addresses the mighty problem of how to
integrate scientific expertise into policy decision-making.
The major institutional shortcomings of EU policies (along with those
of the Member States) were put under the spotlight by the BSE crisis and
triggered a severe crisis of public confidence in both scientific advice and in
the management of risks by EU and Member States authorities. It provided a
classic illustration of uncertainty in science and of the complex and vital
relationship between science and society. Both regulators and the general
public have consequently become increasingly aware of the risks that are
intrinsic to the food industry, whilst the continuous stretching of the frontiers
2 Ellen Vos
of science in areas such as biotechnology have raised public anxiety levels still
further. It thus has become clear that risks must be approached as political
issues. This is all the more the case since their emergence cannot be
dissociated either from the more important transformations within regulatory
regimes (such as food production in the 1980s), or from the resurgence of
contestation and political mobilizations within most European countries (for
example, in relation to GMOs). These crises, scandals and controversies have,
in turn, shaped the way in which risks are perceived and subsequently
managed, with strong implications for understandings of political
accountability, the role of science and stakeholder participation.
Hence, whilst it is true that innovation may improve the quality of life,
and is essential for economic growth, at the same time it raises uncertainties
and concerns, and can bring new hazards to human health and the
environment. Hence, how should regulators react to scientific studies which
show the carcinogenic effects of UV-filters in sun creams, presumably
because they disturb the human hormone balance? And what should they do
with studies indicating that carcinogenic substances (acrylamide) are formed
when baking bread or frying potatoes, and thus pose a health risk when
consumed; or that farmed salmon contains potentially hazardous levels of
dioxins and PCBs?
It is clear that risk governance – embracing risk identification,
assessment, management and communication – has become a crucial but
often highly controversial component of public policy, particularly at the EU
level.
Since the outbreak of the 1996 BSE crisis, there has been much debate
on the role of science in European regulatory decision-making and in
particular on the need to separate risk assessment from risk management. The
Medina Ortega report concluded, inter alia, that the relationship between
scientific and political decisions was blurred. Moreover, it held that the
Foreword and Acknowledgements 3
Commission suffered from poor internal management; decision-making
procedures were not transparent; some national interests held too much
weight in the decision-making process; and the resulting legislative controls
were not effectively implemented. In particular, the existing committee
system was the subject of critique because of its complexity, obscurity and its
undemocratic character. Moreover, the Medina Ortega report concluded that
the EU institutions, the Commission in particular, had failed to take public
health seriously, and that they had attached more importance to the national
interests of agriculture and the interests of industry than the protection of
public health. The Report thus urged greater transparency as regards action
on BSE, particularly in relation to the conditions of the functioning and
contribution of the scientists on the scientific committees; moreover, the
Report stressed the need for transparency and reform of the rules governing
the work of these committees to ensure independence and appropriate
funding of the scientists, and the publication of debates within committee and
any dissenting opinions.
Not surprisingly, in the aftermath of this crisis, far-going reforms were
carried out both at European and national level so as to relate scientific advice
more concretely to the principles of excellence, transparency and
independence, and to allow for greater stakeholder participation. Whilst at
the European level a strict separation between science and politics has been
introduced in the area of food, in other countries a more blurred relationship
between science and politics has been admitted. Moreover, in the aftermath
of BSE, we are witness to an increased emphasis on transparency of science-
and decision-making as well as the participation of stakeholders and the
public.
Based on experience that can be drawn from risk governance in
practice, this volume aims to discuss the role of institutions, both scientific
and regulatory, in European risk governance, and the dialogue that takes
place between risk assessors, risk managers and stakeholders in order to
overcome the crisis of confidence. In this manner, it seeks to define what
4 Ellen Vos
lessons have been learnt and put into place more than 10 years after the
outbreak of the BSE crisis. Are the principles of transparency and
participation truly applied to risk governance, in particular to risk assessment?
What is the impact of the precautionary principle on European decision-
making and the role that science and scientific experts/expertise play in risk
governance (both in the science- and decision-making and before courts)?
Should scientific advice be separated strictly from regulatory decision-
making? In other words: should risk assessment be strictly separated from risk
management? What is the role of agencies in this? Importantly, too, what is
the role of lay people in the production of scientific advice: is science and
scientific advice only produced by the recognised experts (natural science), or
do citizens or specific stakeholders also have a role to play? Should
stakeholders and/or the general public participate in science-making? If yes,
why, in what form and to what extent? To what extent should stakeholders,
civil society and/or the general public participate in decision-making?
In addition, we may observe that the intermingling of public and
private regulation is increasingly used as a tool for effective risk governance.
Here questions are raised as to how emerging public-private partnerships
should be understood and their degree of effectiveness. Do we need more
self-regulation? Do we need more powers at the EU level to control safety
regulation? And, what is the risk of transferring more such powers to
European agencies?
These questions were addressed in the CONNEX workshop that was
held on 14-16 June 2007 at the Faculty of Law, Maastricht University,
Maastricht, The Netherlands (the activity report is available on the
CONNEX website under past activities, http://www.connex-network.org/).
The current Report contains a selection of the papers presented at this
Workshop.
Foreword and Acknowledgements 5
I would like to thank a few colleagues without whom the realisation of
this Report would not have been possible. I would like to thank Morag
Goodwin for the English language correction of all the Chapters. Special
thanks go to Marina Jodogne who provided invaluable assistance through her
able and patient work in the preparation of the camera-ready copy of this
Report. Many thanks also to Laura Tilindyte and Tanja Ehnert who helped
me enormously in the organisation of the workshop, the writing of the
activity report, the proof-reading and the checking of all the footnotes. I
would also like to express my gratitude to the CONNEX-coordinators for
providing me with the opportunity to organise the workshop and to publish
this report. I would like to thank in particular Fabrice Larat and Thomas
Schneider for all their support. Moreover, I would like to thank the
European Commission and the Netherlands Organisation of Scientific
Research (NWO) under the Innovational Research Scheme for financing this
project. Last but not least, I wish to thank Diana Schabregs for all her able
assistance in navigating our way through the financial administration of the
projects.
Chapter 1 European Risk Governance in a Global Context
Michelle Everson and Ellen Vos Birkbeck University of London and Maastricht University
Introduction: The Crisis of Confidence
The ramifications of the BSE crisis of the 1990s have stretched far into the
21st century. The collapse of consumer confidence caused inter alia by
shortcomings in the institutionalisation of scientific knowledge within both
the EU Member States and within the Union itself prompted wholesale re-
evaluation of prevailing structures of science-based decision-making.
However, losses in consumer confidence have not been the only catalyst for
the change in the manner in which we view the legitimate use of science
within government. In addition to the indisputable need for a review of the
quality of scientific advice used to verify agricultural production methods, the
extraordinary degree of public political disquiet about the authorised use of
genetically modified organism within agriculture and industry has raised new
issues about science-based governance. Today, the issue is not merely one of
ensuring that the science used in governance is sound. Instead, thought must
be given to the balancing of scientific opinion against wider ethical and social
values.
8 Michelle Everson and Ellen Vos
Burning cows in English fields and images of slaughterhouses, cattle-
blood and -brains led not only to a fall in beef consumption but also to a drop
in citizens’ belief in the credibility of government. How could citizens ever
trust governance structures which gave priority to agricultural concerns over
the protection of their health?1 Governmental responses entailed institutional
and procedural reform to ensure the quality and transparency of science-based
decision-making, and the participation of citizens throughout the process. A
similar political outcry in relation to the authorisation of GMOs only
intensified the need for such governmental efforts to reform the institutions of
risk governance. In addition to exposing failings in the quality of scientific
advice used within decision-making, the BSE crisis also highlighted problems
of scientific uncertainty. It became common knowledge amongst the public
that scientists would not always have answers to problems of risk. To what
degree would infected beef within the food chain result in full scale infection
of the human population with the new-variant Creuzfeldt-Jakob disease? The
debate around GMOs was not only marked by an even greater degree of
conflict around scientific uncertainty, but also began to raise issues of whether
under conditions of scientific uncertainty, it would be legitimate to demand
that scientific rationalities could ever be overruled by ethical or social values.
New approaches to risk analysis, introduced in the wake of BSE and in
the face of a growing controversy about the authorised use of GMOs, sought
to combat the ‘organised irresponsibility’ (see Beck 1986, 2005) that had
marked much risk policy at both Member States and EU level in the previous
years. Reform was carried through at an institutional level, with a clearer
separation being made between risk assessment and risk management; a
reform which consolidated executive management of risk, making clear
which portions of risk policy would be attributed to scientists and
bureaucracies and the rules under which scientific advice was to be collated
and adopted.2 Further, reform also saw an increase in procedural standards of
European Risk Governance in a Global Context 9
risk oversight, above all with regard to the strengthening of the principles of
openness and participation as well as the precautionary principle, a seemingly
‘neutral’ standard allowing pre-emptive regulatory intervention to combat
uncertain risks (see in particular Fisher 2007).
One side-effect of the effort to regain public trust in the credibility of
risk regulators and regulation was the strengthening of the bureaucracy and
executive centred around risk regulation; the newly consolidated executive,
with its newly apportioned responsibilities within the process of risk analysis,
was to be the main vehicle through which public trust might be regained.
Equally, the consolidation of executive powers and profile within the risk
constellation was only augmented by virtue of the globalisation of markets
and the consequent internationalisation of risks and institutions. Even though
the Commission and other Member States were keen to portray BSE as a
purely British problem, consolidated food markets within the EU ensured
that the Commission and national regulatory authorities were inevitably
confronted with the management of the BSE risk. By the same token, GMOs
are not geographically confined such that a consolidated EU GMO policy
will still require co-ordination with national and international policies and
institutions of market management. Within the ever more global trade
context, normative, practical and legal pressures tend to encourage
networking of executives and of bureaucratic/legal rationales. For example,
the technical standards generated within the framework of the Codex
Alimentarius Commission gain in significance as an evidential aid within the
science-based WTO framework and, thus, inevitably function as a magnet for
the executive agenda-setting preoccupations of national and supranational
bureaucracies such as the European Commission (see Mason-Matthee 2007).
In this ever more global world of risk management, the EU executive
has an increasingly complex task to manage risks. As the most powerful
supranational bureaucracy, the European Commission has unparallel
10 Michelle Everson and Ellen Vos
significance acting as a nodal management structure between national and
international frameworks of risks. In this contribution, we aim to understand
the dynamics of European risk governance and its embeddedness in the ever
more global context of risk regulation.
Science as a Panacea?
Faced with the shortcomings identified above, in particular the European
Commission, in handling the BSE crisis, one line of reform concerned the
separation of risk assessment and risk management at the EU and national
level. As such, it involved conceving of the movement of science, and the
responsibility for scientific advice, out of the traditional executive framework
into independent bodies. From this, regulatory provision that risk assessment
and management must be made institutionally independent from one another
both at European and at Member State level, hereby linking with the
international concept of risk analysis of the Codex Alimentarius Commission,
flowed.3 This new regulatory philosophy whereby the hazard potential is,
where possible, formulated as a quantifiable risk solely with reference to
technical and scientific criteria has thus found institutional approval in the
creation of independent scientific/technical bodies such as the European
Food Safety Authority (EFSA) at the European level and the British Food
Standards Agency (FSA), the French Agence Française de Sécurité Sanitaire des
Aliments (AFFSA) and the Dutch Voedsel- en Warenautoriteit (VWA) at the
national level. By the same token, the risk management function, or the final
decision on the acceptability of risk, is made a clear responsibility of
traditional executive bodies such as the European Commission at European
level and national administrations within the Member States.
Within this emergent regulatory philosophy of rationalisation of risk
assessment and management functions, the growing reliance on technical and
scientific criteria for the framing of the risk problem as well as the mode of
European Risk Governance in a Global Context 11
combating risk interestingly may also extend to constellations of scientific
uncertainty and to the overcoming of uncertain risk. In other words, even in
cases where science cannot adequately quantify risk, or situations in which
there are suspicions of hazard, although scientific or historical evidence is
lacking, rationalising regulatory strategies may yet prevail. Typically,
‘uncertain risks’ concern particular instances of suspected possible hazards that
are usually associated with complex causalities, large-scale, long-term and
trans-border processes, and which are usually difficult to control (see Van
Asselt, Vos and Rooijackers 2008). Equally typically, these uncertain risks not
only reveal the limits of science but also unveil their political character as a
wider public perceives that those hazards could impact negatively upon
society and therefore demand that some action be taken by political actors.
Nonetheless, with a notion of ‘precaution’, constitutionalised within
the European Union as the precautionary principle, uncertain risk may yet be
treated within a rational framework of decision-making devoid of direct
interaction, whether deliberative or otherwise, between societal and technical
values. Alternatively, in one analysis, precautionary action – or the notion
that restrictive interventions are justified where hazard may not be verified in
a quantifiable manner, but qualitative analysis suggests that potential damage is
large-scale, irreversible and impacts significantly upon large sectors of society
– is still founded in rational-technical science.
Fisher’s analysis demonstrates that executives – whether made up of
traditional bureaucratic bodies such as the European Commission or now
found in independent bodies dedicated solely to technical analysis and the
promulgation of science – can restore and secure public faith in the credibility
of risk regulation through application of a rational instrumentalist model of
administrative decision-making (Fisher 2008). Risk may pose great threats to
the joint enjoyment of the social environment. Equally, hazard and uncertain
risk remains a constant source of social anxiety. Nonetheless, the distinction
12 Michelle Everson and Ellen Vos
made between risk assessment and risk management, clear rules guaranteeing
the quality of scientific advice and the independence of experts, together with
the rationalist constitutional reading of the precautionary principle seemingly
provide us with a rational framework that obviates irrationality fears. It thus
ensures that decision-making takes place in a context free from interest
politics and the value irrationalism that otherwise marks unstructured public
political debate.
Offering us a tool to combat the negative externalities of the global risk
society that has developed in tandem with global, liberal patterns of trade and
development, rational instrumentalist philosophies both help to structure
executive action and further facilitate interaction between executives within
the global complex of national, supra-national and international executives.
One language is spoken by all; a language, furthermore, which, with its
Weberian claim to establish common truths out of diversity, is perfectly
suited to the management of risk between diverse societies.
However, the ‘panacea’ of science and instrumental rationality is
perhaps not all it would seem to be. Where it would mean that paradoxically
more resort to science is taken in situations of uncertainty (see Weingart
1999: 151-161), it is by definition in these situations of uncertainty that
science reveals its true limits and that other factors, such as social and ethical
concerns, are bound to play a role. In this way, the European Commission
for example recognises that in situations in which the precautionary principle
is applied, other factors than science should also be taken into account in the
decision-making process.4 Inevitably, this has led to much controversy
surrounding the precautionary principle, where it is considered by some as a
principle that gives almost carte blanche to arbitrary decision-making and by
others as a principle that allows for a more reflexive and pluralistic decision-
making process.5 Interestingly, it is increasingly recognised that there cannot
be a single definition of this principle across the European Union, the
European Risk Governance in a Global Context 13
national levels and the global level, as the principle strongly depends on its
context and the legal culture in which it is embedded (see inter alia, particular
Fisher 2007).
We have already noted that failings within the historical scheme of
‘organised irresponsibility’ for risk regulation led to an immediate crisis of
public confidence and a governance response which stressed the need to re-
establish credibility through the scientification of knowledge production on
risk and the clear apportionment of assessment and management
responsibilities to the traditional executive bureaucracy and newer
independent technical-scientific bodies. This governance response, privileging
technical rationalities and leading to a consolidation of the executive in the
broad sense, was also well suited to the complexities of a global trade regime
and the need to find decisional criteria which might overcome cultural
sensitivities and the clash between economic and non-economic values.
However, the expanded and consolidated executive function which this
evolution has entailed, together with the technically-rational philosophy
within which it is founded, is itself a new governance threat: executives
thrive on consolidation and conformity. Thus, for example, notwithstanding
its recognition that socio-economic values impact upon the precautionary
decisional equation, the European Commission nonetheless seeks to promote
a monolithic conception of precaution, viewed in some sections of society as
an arbitrary yardstick, which fails to take account either of science or of the
very series of diverse social and cultural interests it was designed to protect
(see Fisher 2008).
At one level, the monolithic nature of the principle of precautionary
action that the Commission promotes, raises a very old spectre indeed.
Although he argued in favour of formal bureaucratic rationalities, Max
Weber expressed concern that rationalising tendencies within modernity
would also give new life to the danger of despotic behaviour (Weber 1976).
14 Michelle Everson and Ellen Vos
A rational administration would also be deaf to human concerns that are not
recognisable within rationally structured discourse. Within the expanded and
consolidated executive function, spanning national, supranational and
international entities we might accordingly be concerned that the emphasis
laid on the use of science to define and frame the problems which risk
regulation must address, together with the instrumental rationality that marks
processes of interlinked risk management across the global institutions of trade
regulation, might lead to a fatal disregard for ethical and social sensibilities
(Everson and Eisner 2007).
Equally, however, the spread of the executive function across local
boundaries to embrace a global world can also be argued to obscure the real
rationales that underlie decision-making. As empirical analysis of the case of
Pfizer, a European refusal to authorise the use of particular antibiotics as
growth promoters within European pork markets, demonstrates (Van Asselt,
Vos and Rooijackers 2008), executive decision-makers may be tempted to
hide behind ambiguous scientific findings to pursue their own agendas. In
this case, the European Commission did not listen to the relevant European
scientific body’s conclusion that there was no immediate risk to human health
and preferred to refer to other scientific bodies (the Dutch Health Council,
WHO, UK House of Lords) who adduced scientific uncertainty. On the basis
of the findings of those bodies and some use of the language of the
uncertainty by the European scientific body, the European Commission
constructed its argument of scientific uncertainty that formed the basis of its
precautionary measures: i.e. a ban on the relevant antibiotics on the European
market, whilst it could have more openly acknowledged that the ban was an
outcome of its desire/policy to combat resistance to antibiotics, which is in
fact a human health concern within the Community. On the other hand,
empirical analysis also makes clear that the Commission desperately needs
advice from scientists in what is an area of highly technical and complex
European Risk Governance in a Global Context 15
issues to help them with identifying the human health concerns and to guide
them in their decision-making. For example, one interviewed Commission
official pictured the relationship between the European Commission and
EFSA as being one of a blind driver, the Commission, and a directions-giving
passenger, EFSA (Vos and Wendler 2006: 122).
Seen in this light, the executive nature of global risk governance raises
a dual and interconnected problem of too great an emphasis on the decisional
legitimacy of scientific and technical criteria, together with a refusal to make
transparent the social and economic values that guide decision-makers. The
problem is one of de-politicisation, or, better stated, a politicisation of the
scientific executive function, which might and can lead to obscure and
insensitive decision-making at the level of the simple application of science to
complex social relations, and which might furthermore also deny its own
normative underpinnings or commitment to positive values such as human
health.
In a final analysis, then, the tension between the functionalist necessity
for science-based decision-making and the wider demand for a form of public
participation within risk governance continues to be the primary
characteristic of modern risk governance regimes. The potential inhumanity
and obscurity of a science-based rationally instrumentalist executive must be
balanced by public participation, which is more transparently dedicated to the
re-introduction of ethical and social criteria within the bureaucratic discourse.
At the same time, however, explicitly political debate must be subject to the
limits of science, and more particularly must continue to be disciplined in the
light of neutral, technical-scientific criteria.
16 Michelle Everson and Ellen Vos
Precaution and the Problems of Political Pluralism
If modern schemes of risk governance might be said to be characterised by
ongoing tension between scientific/technical rationalities and the demand for
appropriate consideration of the ethical, social and economic values that may
also be affected by global trade regimes; then, by the same token, the primary
function of risk governance might also be argued to be the effort to bring
scientific rationales and social/ethical values into a lasting equilibrium within
stable institutional structures of governance. As a consequence, the process of
risk management which, as we have seen, is sometimes simply conceived of
as a bureaucratic exercise of adapting regulatory intervention in the light of
technocratic/scientific analysis, might be viewed in a wholly different
manner. Where the task is one of balancing rationales and values, risk
management is a political exercise, a discursive process of the establishment
and implementation of a policy about risk and its regulation.
As the case studies reveal, in practice as well theory, the precautionary
principle is coming to be regarded less as a neutral procedural standard to be
applied in the exceptional context of uncertain risk and more as an institution
in its own right within which risk policy is drawn up. As Rothstein notes in
relation to the activities of the UK Food Standards Agency, recent regulatory
debates within the UK reveal ‘how scientific, normative and institutional
uncertainties provide significant scope for conflict on what constitutes
precautionary action’ (Rothstein 2008). The core of this contention is
provided by the insight that, even in relation to simple (quantifiable?) risks,
‘scientific knowledge does not provide an uncontested universal evidential
basis for decision-making’. Instead, a proposed UK ban on sausage skins
teaches us that where a country has no economic and societal interest in
maintaining a product on its market, it is not difficult to address uncertain
risks within a precautionary action, which was then considered to be
proportional. This was not the case within the whole of the EU, and more
European Risk Governance in a Global Context 17
particularly in Germany where natural sausage skins are used on a very large
scale. The notion of proportional precautionary action allowed the Scientific
Steering Committee at EU level to shift its evidential basis and reject a
precautionary ban on sausage skins on the basis of the relative lack of risk
posed by them in comparison to normal carcass meat (Rothstein 2008).
The perception that precaution is a policy and not a simple neutral
cost-benefit criterion since costs and benefits may vary in relation to the
overall socio-economic context within which risk is posed, is further
confirmed by the legal reasoning structures adopted by US courts in their
oversight of food regulation. Here precaution does not have a meta-legal
status as an independent criterion that may be applied to all cases regardless of
their factual constellation. Instead, it is argued to be a ‘high level policy’
which political actors must use to elaborate particular rules to apply to
particular fact-finding procedures (see Walker 2008). The legal
contextualisation of the principle underlines its relational status. Precaution
and the evidential basis for precaution alters in the light of the particular
circumstances of production, the socio-economics of particular production
processes, as well as with regard to the legal culture within which evidence
for precaution must be established.
The recognition that the evidential basis for precaution and the
evaluation of risk will necessarily fluctuate in light of institutional, social and
economic contexts, in its turn, raises new questions about the renewed
emphasis upon ‘participation’ within governance that we have seen since the
BSE crisis. At one level, the move towards the securing of greater degrees of
public participation within risk governance structures might be considered to
be part of the overall effort to improve regulatory institutional credibility
through greater participation and transparency with the consequential
enhancement of the trust of citizens in the risk management regime.
However, once we have admitted that risk management is itself a necessarily
18 Michelle Everson and Ellen Vos
political process, entailing the weighing of relative substantive costs and
benefits of fluctuating interests, the inevitable political contestation which
such processes entail may also be argued to necessitate public participation
with the executive for other normative and efficiency reasons.
Thus, participation, and more particularly public participation within
institutional structures of risk governance, can serve a variety of rationales. As
has been suggested, in contrast with traditional bureaucratic structures
whereby delegation was itself considered to be a manifestation of public trust
in the efficacy of the executive process, and further, was designed to
overcome complexity in regulatory matters, trust in modern risk management
can only be assured where the public is afforded participatory tools that allow
it to oversee each stage in the management of complex issues. In contrast,
however, public participation within executive structures can also be viewed
to be a part of a general normative scheme of government which demands
that executive action always be integrated within democratic decision-
making. Participation then, in this constellation, is seen as a vital element of
democratic legitimacy. Finally, participation may also be conceived of in an
‘instrumentalist-normative light’, focusing on the quality of the outcome of
the decision-making process, and thus aimed at enhancing the quality of
decisions.6
In this latter perspective, the recognition that scientific evidential bases
are not monoliths, nor are they indisputable truths in their own right, but are
instead both necessary to structure and constrain debate, and are at the same
time, relative both to the institutional context and the material problem
constellation to be addressed, has as its necessary corollary an alteration in the
significance that is attached to the material views and opinions that
participation brings to the risk management and risk assessment process. In
this context, participation does not simply serve abstract normative goals of
government such as enhancing trust or meeting democratic requirements, but
European Risk Governance in a Global Context 19
also acts as a part of knowledge creation itself, as a material contribution to the
evidential bases for assessment and management of risk. In this way,
participation thus aims to enhance the quality of both scientific opinion and the
management decision. By allowing citizens and/or stakeholders to provide
knowledge about the scientific issues at stake on both a scientific/technical
level as well as on the level of ethical and social values, scientists are
confronted with knowledge within a wider context, also allowing for lay
knowledge to be introduced in the ‘hard science’ context (see e.g. Wynne
2001: 445-481). In addition, allowing stakeholders and/or citizens to
participate in management decision-making may also enhance the quality of
the ultimate decisions as they would be able to express themselves on the
management options/preference at hand, thus augmenting the knowledge-
base for decision-making.
Participation as a contribution to knowledge creation seems thus a
sensitive response to the threats thrown up by a global risk governance
regime. Ameliorating the potential ‘inhumanity’, insensitivity and opaqueness
of bureaucratic and scientific rationales, participation as knowledge creation
can be argued to represent a shift within conceptions of governance and to be
a positive response to the complexity of uncertain risks. However,
participation as knowledge contribution must also be recognised to give rise
to its own particular problems of the institutional structuring of risk
governance. In contrast to traditional bureaucracies which ensured unitary
and universal decision-making through the exclusion of public participation
from implementation processes, the re-evaluation of participation as a positive
contribution to knowledge creation also demands that we identify
institutional mechanisms and procedures which reconcile potentially
irreconcilable rationalities of science and ethics, and which further guard
against executive capture by inappropriate interests, or even an utter collapse
in the executive function as plural processes of knowledge creation descend
20 Michelle Everson and Ellen Vos
into meaningless and fruitless conflict between varied views and interests.
Historically, trust was a communitarian good established within normal
political processes. It predated and justified delegation in the effort to reduce
regulatory complexity.
Three Models of Plural Risk Governance
In the preceding sections we argued that within the traditional models of
bureaucracy maintained within the nation states of modernity, the major
concern was one of ensuring the authority of bureaucratic rationales and
decision-making through a strict delimitation between political processes of
policy and decision-making and bureaucratic processes of implementation.
The plurality of interests which circle each regulatory task were first
neutralised within the conventional democratic processes of the national
polity; subsequently, a unitary will for action was transmitted to an
implementing executive. Within plural global risk governance structures
contestation continues between scientific and ethical/social rationales as well
as between diverse interests from the moment of problem definition through
to the point of regulatory intervention of the establishment of a precautionary
approach. Here the problem is a heightened one, both of the identification of
a principle that might reconcile conflicting rationalities and that may
legitimate a final (universal) decision, which transcends all particularistic
interests that arise within particular constellations of risk.
Broadly speaking, we may distinguish three models within which we
might begin to conceive of a plural risk governance institutional structure and
within which the dangers of particularistic plural contestation and a lack of
final regulatory authority might be combated.
1) For the political scientist Andreas Klinke, the primary problem is
one of how the identification of a universal rationality of ‘justice’ within
European Risk Governance in a Global Context 21
scientific and ethical-social rationalities may be reconciled and the varying
cost-benefit calculations of individual actors be conflated. The process of
global risk management must be dedicated to the identification of a ‘common
good’ that will then legitimate the final decision. However, this model of ‘the
common good-orientation’ of risk management strategies also raises the question of
inclusion or exclusion, whose good ought to be taken into account and,
what, substantively-speaking is the common good’ (Klinke 2008). To Klinke,
a deliberative conception of the common good is the only possible outcome.
Certainly, ‘resort may be made to the category of justice’; however, justice
will necessarily be a ‘relational’ concept to be established in each concrete
case of risk management by constant cognitive reflection by and between all
interested parties.
At the practical of institutional design, then, global schemes of risk
governance must be informed by, and processes of risk management are only
legitimated by, ‘inclusive risk governance through discourse, deliberation and
public participation’. Publicly acceptable common good rationality is a
product of a political pressure which ensures that policy-making and advisory
bodies consider and condense unadulterated and reliably collated public
opinion and input throughout the whole of the risk governance process. The
model is one that locates authority for final decision-making within
constitutive deliberation, whereby no one rationality can ever claim to
represent and embody objective criteria for decision-making: the common
good is an epistemological product of concrete deliberation (Klinke 2008).
2) The notion that decisional authority can never be derived from one
rationality but must instead be teased out of deliberation between competing
and contested rationalities is one which science also recognises. The model of
‘sound science’ can be distinguished as a second model. It extends deliberation
into the process of risk assessment and the amelioration of the public
sensitivity of science by contrasting the scientific rationales with varying
22 Michelle Everson and Ellen Vos
public ethical and social concerns at the very point of the creation of the
scientific knowledge base. In this model, active stakeholder participation may
occur at a number of levels, for example ‘(i) during the process of problem
identification; (ii) during the organisation of the risk analysis process, and,
above all, decisions about who should participate within that process; (iii) in
relation to the identification of the relevant technical, social and economical
parameters that should be applied during risk analysis; (iv) with regard to the
establishment of judgement values on the acceptance and mitigation of
identified and characterised risks; and (v) with regard to the measures to be
taken to monitor and control risk factors that have already been released into
the environment’ (Kuiper 2008).
The pivotal point to note is that although the common good cannot be
found within the purported ‘objective’ criteria to be found within any one
rationality (scientific, bureaucratic, social or ethical) and must instead be
established by the constant deliberative process of cross-referencing between
competing rationalities, the institutional structures and procedures of global
risk governance must also take care never to dilute the individual rationalities
that are brought to bear upon the search for a common good and decisional
authority. Science must not be contaminated by ethical considerations.
Likewise, the ethics and social mores current amongst and supported by a
wider process of public participation may not simply be set aside with
reference to scientific criteria. This process of constitutive deliberation
founded within mutual respect and cross-referencing between rationalities
likewise finds a supportive partner within the disciplines of law and
administrative design.
3) A third model, ‘administrative constitutionalism’ (Fisher 2007) or
‘reflexive proceduralism’ (Everson and Eisner 2007), focuses upon a reorientation
of the logics that drive institutional administrative design and legal oversight
of risk regulation. Neither the institutions of risk management, nor the law
European Risk Governance in a Global Context 23
that oversees them, can claim to embody or apply substantive criteria to
legitimate constitutive deliberation. Constitutive deliberation cannot be tested
or ensured simply within the logic of scientific discourse. Nor can it be
measured purely against ever changing ethical and social mores. Accordingly,
both the notion of administrative constitutionalism and the notion of
reflexive proceduralism aim to secure a change in administrative and legal
cultures. The administration may no longer simply rely on instrumental
rationalism. Law cannot simply promote science. Instead, both administrative
design and law must be dedicated to ensuring that constitutive deliberation
between competing rationalities and interests is promoted and structured to
ensure respect for contestation within the risk governance regime and,
further, they must establish a clear set of procedures and rules which address
conflict. Most importantly, legal and institutional structures guiding
constitutive deliberation are not simply concerned with the provision of a
neutral forum for debate between conflicting rationalities. Instead, both aim
to guarantee the quality of this debate by ensuring that each scientific, rational
or ethical rationality promoted within the global risk governance regime is
not simply subsumed within an obfuscating melting pot of values, but instead
retains its own integrity and, thus, ability to convince in concrete cases. Thus,
concrete administrative and legal structures are likewise used to enhance the
philosophy of constitutive deliberation, further strengthening discursively
established legitimacy through procedural values of transparency,
participation, independence and excellence.
European Risk Governance in the Global Context:
The Cases of Food and GMO Regulation
With its constitutionalised precautionary principle and its ever more
differentiated institutional efforts to rationalise the process of risk regulation
and scientific uncertainty, the European Union might initially appear to have
24 Michelle Everson and Ellen Vos
developed the most streamlined of responses to risk and scientific uncertainty.
However, when we investigate the specific examples of food and GMO
regulation, the hidden subtleties and complexities of both risk and regulatory
intervention become apparent. They demonstrate the particular difficulties of
acts of risk assessment and management in light of long-standing contestation
between industrial and consumer interests that are difficult to maintain in
equilibrium within institutional structures. Which forms of food might be
deemed safe? Should we pay greater attention to the efficiency demands of a
global food market for consolidated foods standards than to local perceptions
of food as a product anchored within ethical and social values? How might a
European executive best mediate between global trade efficiency interests and
national/local preconceptions about the cultural embedding of food? By the
same token, case studies on GMOs unveil the difficult demands made upon a
European executive in relation to the structuring of public participation
within the regulatory regime and the effort to reconcile the ethical and social
demands that public participation entails with the more rational interests and
outlook of a global market and of global and European institutions of legal
regulatory oversight. Such case studies are exemplary for the way in which
‘contested governance’ and (dis)trust challenge the legitimacy of existing
institutional arrangements (Ansell and Vogel 2006: 10).
Above all, the current global framework for risk governance,
encompassing national regulation, supranational regimes and international
regulatory bodies and treaties, is still strongly characterised by inherent
tension between instrumentalist rationality and demands that political
participation and, above all, the ethical and social values that participation
entails, be better structured and given a clearer profile within risk governance
structures. In practice, the global risk regime presents us with a paradox, a
dual and intertwined process of re-scientification and re-politicisation,
whereby neither scientific/technical rationales, nor political deliberation are
European Risk Governance in a Global Context 25
properly structured or secured to ensure the integrity of the risk governance
regime.
As noted, maintenance of the integrity of scientific discourse is a vital
component within risk governance regimes. Scientific discourse is a universal
discourse that creates objectives values, which may be tested and which in
turn may be used to test the validity claims of other political, social or ethical
discourses and, above all, may be used to unveil hidden motivations, such as
protectionism or the hidden evolution of, say, health protection policies
within competing rationalities. At the same time, however, scientific
rationalities, if never challenged within competing discourses, can prove to be
insensitive to established ethical values and simple social realities. If further
embedded within expansionist executive and bureaucratic logics and
rationales, science and technical rationality harbour the potential to
disenfranchise necessary political debate and to contribute instead to the
expansion of a hegemonic executive function.
Pressures for the re-scientification of the European and global risk
governance regimes are manifold. However, perhaps the most powerful of
pressures for re-scientification remains the ‘global’ nature of trade, which,
when taken together with the political aspirations of individual segments of
the global risk governance executive, sees actors motivated to use the
universal rationality of science to gain the upper hand within interconnected
national, supranational and international regimes (see Scott 2008). Thus, for
instance, we witness the curious efforts of the European Commission to
colonise the standard-making procedures of the Codex Alimentarius
Commission by asserting the overwhelming scientific excellence of the
activities of the European Food Safety Authority (see Vos and Wendler 2006:
128). Thus, the argument is made, this excellence should – for wholly
rational reasons – be deployed in the global effort to identify a ‘state of the
art’ for food standards that will apply throughout the whole of global trade. A
26 Michelle Everson and Ellen Vos
fine and worthy endeavour? Perhaps not: the Commission’s efforts to
colonise the Codex using scientific rationale is surely also informed by
political motivations and, more particularly, by the WTO recognition of the
Codex as a state-of-the-art set of standards, which means that they might
then form the evidential basis for evaluation of potentially restrictive
precautionary regulation at national and supranational level (see Mason-
Matthee 2007).
At once, science has become a tool in the endless controversy between
US and European regulatory regimes that centres on WTO dispute
settlements. The exact significance of scientific rationality within this dispute
is highly opaque. The GMO dispute, recently heard by a WTO panel,7
presents us with a scenario whereby the EU has chosen to allow its member
states to continue to apply precautionary regulatory provisions, which appear,
in the eyes of the US regulatory regime, to have very little to do with
scientific and market rationalities and, instead to represent the continuing
pre-occupation of European market cultures with the maintenance of cultural
traditions within modes of production (see Joerges 2008; Joerges and
Petersmann 2006: see also Zürn and Joerges 2006). Above all, the continuing
restrictions placed upon GMOs reflect a ‘European’ notion that a (food)
product is more than simply an end product but also encompasses the mode
of its production: cheese is only cheese and beer is only beer where the same
production methods have been used for generations (Everson and Joerges
2006). The old world ‘feudalism’ of such constructions are a necessary affront
to US market liberalism; an affront that they seek to overturn with reference
to scientific rationality. In this view, the European notion of precaution is
context-based, founded not in rational, objective and universal criteria but in
the social constructions of European markets, taking into account, next to
scientific rationales, other legitimate and lifestyle concerns of European
citizens. This kind of thinking and argumentation will be tested as soon as the
European Risk Governance in a Global Context 27
EU labelling regime on GM products is challenged before the WTO dispute
body.
What then of the strategic use of European science to capture and
colonise the Codex? Are we witnessing the de-politicisation of the Codex
Commission and the establishment of a hegemonic rational discourse of
science? Alternatively, is this trend just one further strategic European effort
to assert its context-based evidential bases above US market liberalism and
scientific rationality? The intertwined, yet not fully integrated, structures of
governance within the global trade market make it very difficult to determine
what form of science and what form of executive political action is taking
place.
The strategic use of science perhaps has its most important
manifestation within the global context of risk governance. However, this is
not to say that re-scientification and the use of science to dominate political
debate is not also present at more local levels. Above all, national authorities
within the European Union have often been forced to deploy scientific
rationality, not simply since they embody empirical truths, but rather since
they are a convenient tool to set aside inconvenient interests that may block
trade in particular products; a trend most apparent within the early efforts to
establish new scientific structures for food regulation in France (Noiville
2008). By the same token, however, they may also be used to create or
maintain barriers to trade. Thus, French authorities were also quick to seize
upon science and the notion of scientific uncertainty to justify their
continuing refusal to lift their ban on British beef following the BSE crisis
(Besançon and Borraz 2008).
So, what is the real danger posed by re-scientification of the spread of
instrumental rationalism through global structures of risk governance? Is it
perhaps seen most clearly in the tortuous re-alignment of once hierarchical
structures of political control of foodstuffs in Poland to suit the demands of
28 Michelle Everson and Ellen Vos
the integrated European market for clear distinctions between risk assessment
and risk management (Surdej and Zurek 2008), where it is felt that a scientific
rationality with no sensitivity towards human social and ethical concerns will
simply sweep away all of our more refined notions that goods are also the
sum effect of their socially-embedded modes of production? Alternatively, is
it that an ever expanding global executive function it itself poses a danger to
the integrity of the evidential scientific knowledge base for decision-making,
proving itself all too willing to use and misuse science in a strategic manner
that obscures an underlying confusion of scientific, ethical and social
rationalities?
Clearly, the solution to both such dangers is a re-politicisation of the
risk governance regime, which makes use of the legitimating quality of ethical
and social values within the deliberatively constitutive debate on the nature of
risk and the status of scientific uncertainty. The integrity of science itself can
surely only be assured where transparent frameworks of discourse recognise
the contested nature of risk governance allowing political and ethical
concerns to be given explicit expression rather than be hidden within or
behind instrumentalist scientific rationalities. At the same time, however,
participation, allowing for the expression of social and ethical values can help
to place truly universal scientific rationality in its necessarily embedded social
context, enabling the establishment of equilibrium between competing and
contested discourses.
However, at a practical level of risk regulation we can again see that
equilibrium is far more easily established in practice than in theory. The
problem is not simply one that participation tends only to occur at national
level and cannot easily be accommodated within the bureaucratic and legal
rationalities that characterise the essential interlinking institutions of risk
governance within the global trade regime. The structures of the Codex
Alimentarius Commission are thus not easily opened up to diffuse public
European Risk Governance in a Global Context 29
debate and instead can only be made accessible to stakeholders, with all the
fears of regulatory capture that such a constellation gives rise to. By the same
token, however, the legal rationality of, say, WTO panels is of necessity
closed to direct public interest participation: law decides issues in isolation.
Rather, the problem is a far deeper one of a failure to identify the criteria that
allow for the reconciliation of ‘incommensurate rationalities’. The dicta of
Max Weber still hang heavily over our modern efforts to establish a universal
decision-making that gains its authority from the willingness of all parties to
the process to recognise the quality of the final decision.
In the absence of one overarching rationality that allows the process of
contestation to be brought to its natural conclusion through the exclusion of
all competing rationalities from the final decision, the tendency remains one
of bad structuring and possible misuse of participation. Thus, GMO debates
in both the Netherlands and the UK reveal that participation is not viewed as
a means to enhance the quality of debate and the decision by means of mutual
re-adjustment of the evidential bases for scientific uncertainty, but is instead
reduced down to its lowest common denominator: with the UK
Government viewing participation as a means to educate the public in
scientific rationalities (Lee 2008) and the Dutch Government treating
participation as a simple exercise in democratic legitimation and trust
enhancement, final decisions were still to be take apparently within the
rationality criteria of science and the market leaving the indelible impression
that all social and ethical criteria raised in debate were simply extraneous to
the final decision-making process (Somsen 2008).
Concluding Remarks
In the effort to re-establish the credibility of risk governance following the
BSE crisis, many institutional and procedural reforms, encompassing greater
independence for the scientific knowledge-base and greater public
30 Michelle Everson and Ellen Vos
participation within decision-making, have at the very least helped policy-
makers, the public and academics in their efforts to enhance the quality and
legitimacy of decision-making on risk and uncertain risk. However, each
reform also reveals the complexity of the regulatory problem to be addressed
as the gap between scientific rationality and trust has proven to be difficult to
address in practice.
However, in the continuing effort to bridge demands for safety and for
trust we can now begin to sketch out the vital elements within an effective
global risk governance regime. The conceptualisation of participation helps us
also to identify in which cases and under which conditions participation
should be allowed. Above all, participation must serve to improve the quality
of decision-making and be recognised as a vital substantive element within
the knowledge base for decisions on scientific uncertainty. The substantive
rationale of participation pleads for some form of participation by stakeholders
in science-making itself so that knowledge can be transferred to the risk
assessors, which will lead to better scientific opinions. Using a theatre
metaphor, Stephan Hillgartner suggests that both transparency and
participation should not be about dissolving the difference between onstage
and backstage of science- (and decision-)making but more about creating
public spheres in which differences in opinion can be ventilated and
viewpoints can be exchanged and discussed between all relevant parties
(Hilgartner 2000). Other authors suggest that expert bodies should open up
to scientific uncertainty and reveal the uncertainties at stake, which would
avoid the situation wherein the risk managers hide behind science and
experts. This would imply that scientific bodies should not only include
experts on the relevant issues of uncertain risks, but also experts who are
tolerant towards uncertainty so that they may ‘neutralise’ the production of
plausibility proofs with the help of uncertainty language whilst they can also
help to frame and phrase scientific opinions so as to make them
European Risk Governance in a Global Context 31
understandable for a lay public. Further suggestions for reform relate to the
proceduralisation of the precautionary principle and the stimulation of more
independent research carried out by public scientific bodies themselves (Van
Asselt, Vos and Rooijackers 2008).
Linking these empirical reform suggestions back to the structural
theories of administrative constitutionalism and reflexive proceduralism,
future global risk governance should seek to establish its own constitution,
which not only secures the vital independence and transparency of scientific
advice, but also guarantees public participation, whether by stakeholders or a
wider public, to ensure that scientific rationality, even as it is used to
discipline the potential irrationalities of political debate, is nonetheless not the
sole criterion for risk decision-making. Instead, individual rules must be
developed within the ambit of a procedural understanding of the
precautionary principle, which recognises the case specific context of a
definition of scientific uncertainty and which ensures rationalisation of public
participation and a widening of the knowledge base upon which precaution is
established. Rationality in this latter sense is inextricably linked with notions
of transparency. Decision-making in situations of uncertain risk can and often
must also be political in nature. The theatre metaphor teaches us that we
should not strive for an opening up and shedding light on the ‘backstage’
activities of both scientific and political bodies, but instead that we create
public areas of discussion. Hereby it is of utmost importance that when
upholding the separation between what is happening on- and backstage,
scientific and political bodies will not be secretive about their ‘backstage’
activities. Transparency about the arguments and science used, the values
involved and the way they have been addressed as well as the procedure
followed should guarantee that no capricious and arbitrary science-and
decision-making takes place and show how science and non-market values
have been balanced.
32 Michelle Everson and Ellen Vos
Notes 1 See as regards the UK, BSE Inquiry Report, 2000, at
<http://www.bseinquiry.gov.uk/report/index.htm> and as regards the EU, Medina Ortega
Report, Inquiry Committee set up by the European Parliament (1997), A4-0020/97/A, PE
220.544/fin/A. 2 See e.g. the contributions by H. Rothstein, J. Besancon and O. Borraz, A. Surdej and K.
Zurek, B. Van der Meulen and E. Vos in Everson and Vos 2008. 3 Working Principles for Risk Analysis, Codex Alimentarius Commission – 14th Procedural
Manual. 4 CEC, Commission of the European Communities, Communication on the precautionary principle,
COM(2000) 1, 2 February 2000, Brussels. 5 See e.g. as regards the former e.g. Forrester and Hanekamp 2006: 1013-1019; Marchant and
Mosman 2004. As regards the latter e.g. de Sadeleer 2005, 2006. 6 See Harremoës, Gee, MacGarvin, Stirling, Keys, Wynne and Guedes Vaz 2002. Stirling
makes a threefold distinction for participatory engagement rationales: normative democratic
(‘because it is the right thing to do’); substantive (‘because it leads to better decisions’) and
instrumental (‘because it facilitates particular favoured decisions’). See Stirling 2003: 381-401. 7 See for a discussion of this case e.g. Prévost 2007: 67-101.
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National, European and International Context (London: Routledge-
Cavendish Publishing).
Marchant, G. E. and K.L. Mosman (2004), Arbitrary and Capricious: The
Precautionary Principle in the European Courts (Washington DC: AEI
Press).
Mason-Matthee, M. (2007), The Codex Alimentarius Commission and its
Standards (The Hague: T.M.C. Asser Press).
Noiville, C. (2008), ‘The French Regulatory System on GMOs’, in Everson,
M. and E. Vos (eds.), Uncertain Risks Regulated in National, European and
International Context (London: Routledge-Cavendish Publishing).
European Risk Governance in a Global Context 35
Prévost, D. (2007), ‘Opening Pandora’s Box: The Panel’s Findings in the
EC-Biotech Products Dispute’, Legal Issues of Economic Integration 34: 1,
67-101.
Rothstein, H. (2008), ‘The Origins of Regulatory Uncertainty in the UK
Food Safety Regime’, in Everson, M. and E. Vos (eds.), Uncertain Risks
Regulated in National, European and International Context (London:
Routledge-Cavendish Publishing).
de Sadeleer, N. (2005), Environmental Principles: From Political Slogans to Legal
Rules (Oxford: OUP).
de Sadeleer, N. (2006), ‘The Precautionary Principle in EC Health and
Environmental Law’, European Law Journal 12: 2, 139-172.
Scott, J. (2008), ‘European Regulation of GMOs, Thinking About ‘Judicial
Review’ in the WTO’, in Everson, M. and E. Vos (eds.), Uncertain
Risks Regulated in National, European and International Context (London:
Routledge-Cavendish Publishing).
Somsen, H. (2008), ‘GMO regulation in the Netherlands: a story of hope,
fear and the limits of ‘poldering’, in Everson, M. and E. Vos (eds.),
Uncertain Risks Regulated in National, European and International Context
(London: Routledge-Cavendish Publishing).
Stirling, A. (2003), ‘Beyond Public Perceptions of Gene Technology:
Community Participation in Dietrich and Schibeci’, Public
Understanding of Science 12, 381-401.
Surdej, A. and K. Zurek (2008), ‘Food Safety in Poland: Standards,
Procedures and Institutions’, in Everson, M. and E. Vos (eds.),
Uncertain Risks Regulated in National, European and International Context
(London: Routledge-Cavendish Publishing).
Vos, E.I.L. and F.A. Wendler (2006), ‘Food Safety Regulation at the EU
Level’, in Vos, E. and F. Wendler (Eds.), Food Safety Regulation in
36 Michelle Everson and Ellen Vos
Europe. A Comparative Institutional Analysis (Ius Commune
Europaeum, 62) Antwerp: Intersentia, 65-138.
Walker, V. (2008), ‘A Default-Logic Model of Factfinding for United States
Regulation of Food Safety’, in Everson, M. and E. Vos (eds.), Uncertain
Risks Regulated in National, European and International Context (London:
Routledge-Cavendish Publishing).
Weber, M. (1976), Wirtschaft und Gesellschaft. Grundriß der verstehenden
Soziologie (Tübingen: Mohr).
Weingart, P. (1999), ‘Scientific expertise and political accountability:
Paradoxes of science in politics’, Science and Public Policy 26:3, 151-161.
Wynne, B. (2001), ‘Creating public alienation: expert cultures of risk and
ethics on GMOs’, Science as Culture 10: 4, 445-481.
Zürn, M. and C. Joerges (2006), Law and Governance in Postnational Europe.
Compliance Beyond the Nation-State (Oxford: OUP).
Chapter 2
EU Risk Regulation and Science: The Role of Experts in Decision-making an Judicial Review
Alberto Alemanno European Court of Justice, Luxembourg
Introduction
This Chapter aims at exploring the role that scientific experts and, more
particularly, scientific expertise play within European risk governance. While
the first part of the Chapter looks at the way in which scientific expertise is
integrated into the decision-making process, the second part examines how
science and science-based measures are, or may be, judicially reviewed by
European courts. This last part also ventures to suggest some ways to help the
judge when reviewing science-based measures by looking into expert
consultation systems and peer review mechanisms.
In taking this approach, the Chapter will focus primarily on the area of
food safety, as it provides a privileged perspective from which to examine the
emergence of a European risk regulatory framework. Indeed, although
confined to regulating food safety issues, the risk regulatory model laid down
by EP and Council Regulation 178/2002 in the aftermath of several food
scandals reflects the state of the art in ongoing European reflection about risk
governance.1
38 Alberto Alemanno
Scientific Expertise in Decision-Making
The Genesis: the Role of Science in EC Law
Today the use of science as one of the sources of evidence to support
decision-making is relevant in a wide range of policy areas, such as food
safety, emission limits,2 chemicals,3 biocides,4 GMOs,5 pesticides,6 food
additives,7 water protection,8 consumer protection, worker safety and health.9
As scientific evidence is crucial at all stages of the drawing up of new
legislation and for the execution and management of existing European and
national legislation, it is worth illustrating how this process has occurred
within the European legal order.
The original 1957 Treaty of Rome did not impose either on the EC
institutions or on Member States a duty to justify their health, safety and
environmental protection measures according to the latest scientific
information. Indeed, its text did not contain any reference to scientific
justification or expertise.
However, as Member States began invoking Article 36 (currently
Article 30) EC, which allowed them to adopt restrictions on trade justified
inter alia on grounds of protection of health,10 they often submitted scientific
evidence to the European Court of Justice in order to demonstrate that their
measures were covered under this exception. Thus, for instance, in the Beer
Purity case,11 Germany, after having banned the marketing of beer containing
any additive (not just those additives for which there was evidence of risks),12
tried to justify its measure by arguing not only that Germans drank a lot of
beer (sic), but also that the long-term effects of additives were unknown. To
support its scientific claim, Germany also cited experts' reports referring to
the risk inherent in the ingestion of additives in general.13 Moreover, it was
not just the parties to the case that picked up on the scientific element, but
also the Court. The ECJ, referring to the previously decided Sandoz,14 Motte15
and Müller16 judgments, held that a Member State’s possibility to restrict the
EU Risk Regulation and Science 39
free movement of a foodstuff legally marketed in another Member State is
subject to ‘the findings of international research, and, in particular, the work of
the Community's scientific committee for food, the Codex alimentarius
committee of the FAO and the World Health Organization’.17 Having
deferentially referred to the scientific findings of these entities, the Court,
however, found that not only did the additives not present a risk to public
health but also that the German policy was inconsistent insofar as it allowed
the use of these same additives in other drinks. References to ‘the findings of
international scientific research, and in particular of the work of the
Community's Scientific Committee for Food, the Codex alimentarius
Committee of the Food and Agriculture Organization of the United Nations
(FAO) and the World Health Organization’ may also be found in subsequent
judgments, such as Bellon18 and Debus,19 both involving national measures
restricting the use of additives.20
Thus, without being formally introduced within the Rome Treaty, a de
facto scientific requirement grew up within the regulatory practice developed
around the rules governing the free movement of goods within the EC.
However, it was only in 1999 that scientific justification was expressly
inserted into Article 95, paragraph 5, as one of the requirements Member
States must satisfy in order to introduce a measure derogating from European
harmonisation legislation.21 In particular, a Member State that deems it
necessary to introduce a national measure aimed at the protection of the
environment after the adoption of a Community measure on the matter must
provide ‘new scientific evidence’.22
As a consequence, an embryonic scientific discipline has evolved over
time not with the purpose of protecting human health but rather of resisting
national protectionism, and thereby of permitting the establishment of the
internal market.
40 Alberto Alemanno
At the same time, the scientific justification discipline that originally
developed in relation to Member State measures based on public health had
been extended to the acts adopted by the European institutions. In 1992,
when the aim of achieving a ‘high level’ of health was given the status of a
general objective in the EC Treaty (Article 3, paragraph 1, (p)), a specific
legal basis has been laid down in Article 152 EC for public health measures.
Moreover, in the same year, EC environmental policy was redirected to the
attainment of a ‘high level of protection’23 and, to this purpose, it was
required to ‘take account of available scientific and technical data’.24
Subsequently, in 1997, Article 100a (current 95 EC), which allows the EC
institutions to adopt directives aimed at harmonising national provisions that
‘directly affect the establishment or functioning of the common market’, was
amended in order to specify that these objectives should be pursued and based
on ‘scientific facts’.25
Thus, from the moment that the Amsterdam Treaty entered into force
in 1999, all Community legislation concerning health, safety and
environmental and consumer protection is to aim at achieving a high level of
protection by ‘taking account in particular of any development based in
scientific facts’.26 This is because the Commission intends ‘to use this advice
for the benefit of the consumer in order to ensure a high level of protection
of health’.27 As the Commission has pointed out in its 1997 Communication
on Consumer Health and Food Safety:
‘[…] scientific evidence is of the utmost importance at all stages of the drawing up of new legislation and for the execution and management of existing legislation’.28
Recently, scientific justification has been expressly defined as ‘an essential
requirement for Commission proposals, decisions and policy’ relating to
consumer safety, public health and the environment.29 To fulfil its function,
EU Risk Regulation and Science 41
scientific advice on matters relating to consumer health must be based on the
principles of excellence, independence and transparency.30
These are the only references contained in the Treaty laying down a
general duty for the EC and national decision-makers to provide for scientific
justification when adopting legislation concerning consumer safety, public
health and the environment. However, although it establishes a risk
assessment duty, the Treaty does not define who is charged with ensuring
such an assessment by leaving open the controversial question of whether risk
assessors should be distinguished from those who have to decide if and how
to act. In other words, our analysis shows that the Treaty does not set forth a
complete risk analysis model aimed at defining the role of the different actors
involved in such an analysis. As a result, it is up to the secondary legislation to
do so by choosing the risks assessors and establishing their relationship with
the risk managers.
EC Sources of Scientific Advice and Expertise
Contrary to conventional wisdom, there is currently no common system
providing scientific advice to EC policy-makers. Scientific support is ensured
through a range of different mechanisms, depending on the policy area at
issue.
The most common sources of advice used to support EC policies,
legislation and regulatory decisions are the following: scientific committees
under the control of EFSA and EMEA,31 three non-food scientific
committees that operate under the responsibility of the Directorate General
for Public Health and Consumer Products (DG SANCO),32 reports by
advisory agencies, such as the European Environmental Agency (EEA);
reports provided by external consultants (individuals, groups or companies,
possibly using research contracts); national reports provided by Member
States' advisory bodies; reports by ad-hoc expert groups; in-house analysis
42 Alberto Alemanno
conducted by Commission officials; reports and opinions by the Joint
Research Centre (JRC) and the Scientific and Technical Options Assessment
group in the European Parliament (STOA).
In an attempt to ensure some consistency in the delivery of advice from
so many different sources of expertise, the EC Commission has developed a
set of policies and guidelines for the use of scientific advisors. This growing
scientific advice policy is contained in three main documents: the Science and
Society Action Plan (2002), the Commission Communication on the
Collection and Use of Expertise (2002),33 and the Commission Decision to
set up Scientific Committees in the Fields of Consumer Safety, Public Health
and the Environment (2004).34 These documents impose ‘sound and timely
science’ as an essential requirement for risk management in the areas of
consumer safety, public health and the environment, and they recommend a
set of guiding ‘core principles’ for the collection and use of scientific expertise
by the Commission departments: quality, openness, effectiveness,
independence, pluralism, excellence, impartiality, proportionality and
transparency.35
Moreover, since 2000, some efforts have been made at setting up a
harmonised approach to risk assessment procedures among the Scientific
Committees advising the European Commission in the areas of human,
animal and plant health and on the environment.36
However, these principles and guidelines are not legally binding. Nor
do they apply to the formal stages of decision-making as provided by the
Treaty and in other EC legislation. Therefore, the formal legislative
procedures as well as the formal exercise of the Commission’s implementing
powers through the ‘comitology’ committees are excluded from their scope.
EU Risk Regulation and Science 43
The Emerging EU Risk Regulatory Framework
The Principle of Risk Analysis
To understand the role played by experts within the European decision-
making process, it is necessary to describe the context within which they are
expected to provide their advice. If one looks at the European risk regulatory
framework as it emerges from the general food regulation, this framework
contains the following three different components: risk assessment, risk
management, and risk communication.
As is well known, this structured approach incorporating the three
distinct but closely linked stages of risk analysis was firstly developed and
popularized by the US National Research Council (NRC)37 and today finds
support in the main guidelines developed by national and international
organisations dealing with risk analysis.38
In particular, the EC food risk analysis model interprets and promotes
the relationship between risk assessment and risk management in terms of
clear-cut separation, by giving, for the first time, a normative expression to
the ‘functional separation’ between these two components.39 The primary
reason given for such a distinction or separation between these two
components of risk analysis is a desire to ensure the independence and
objectivity of the scientific process as conducted during the risk assessment
stage. The idea is that only the introduction of a clear-cut separation between
risk assessors, who discuss facts, and managers, who discuss values, would
effectively insulate scientific activity from political pressure and, accordingly,
maintain an analytical distinction between the magnitude of a risk and the
cost of coping with it. Following the development of this design, several steps
have been undertaken within the Commission to institutionally implement
this approach to risk analysis by functionally separating those responsible for
production, or the promotion of the market, from those responsible for the
assessment of food safety. Thus, for instance, the management of the scientific
44 Alberto Alemanno
committees was transferred to what is now the Directorate General for
Health and Consumer Protection (DG SANCO), and subsequently to the
EFSA, a supposedly independent scientific body lacking any decision-making
power. Thus, a watertight separation between the risk assessment and risk
management stages in the field of food safety has been increasingly seen as
essential not only to guarantee independence and objectivity to the scientific
process,40 but also as a means of enhancing the democratic legitimacy of the
decision-making process by ensuring that decisions are ultimately taken by
those who are accountable to the public.41 According to A.G. Mischo, this
distinction meets a dual goal: it ensures a rational technocratic dimension to
the decision-making process, while enabling the political process to be
independent from the results of scientific assessments.42
Finally, the duty to rely on scientific expertise appears to have been
given general application to all science-based measures by the Court of First
Instance (hereinafter: the ‘CFI’), which has stated that
‘when a scientific process is at issue, the competent public authority must, in compliance with the relevant provisions, entrust a scientific risk assessment to experts who, once the scientific process is completed, will provide it with scientific advice’.43
The EU’s Approach to Risk Analysis
Under the emerging EU Risk Regulatory framework, once a risk has been
identified, it is the decision-maker’s responsibility to decide if it is acceptable,
which may imply adopting an attitude of zero tolerance. In particular, risk
managers (EC institutions and Member States’ authorities) have to take into
account:
a) the results of risk assessment, in particular the ‘opinions’ of the EFSA;
b) ‘other factors legitimate to the matter under consideration’ (the so-called
‘social factors’ (Echols 1998: 530) or ‘non-economic factors’), and
EU Risk Regulation and Science 45
c) the ‘precautionary principle’, within the limits laid down in Article 7 of
the Regulation 178/2002, in order to achieve the general objectives of
food law.
Then, Article 5, paragraph 3, adds to this list:
d) ‘international standards […] except where such standards or relevant parts
would be:
a) an ineffective or inappropriate means for the fulfilment of the
legitimate objectives of food law, or
b) where there is a scientific justification, or
c) where there would result in a different level of protection from the
one determined as appropriate in the Community’.
Therefore, although science plays the major role in the risk management
stage, the Regulation reserves the right of risk managers to take other factors
into consideration when reaching a final decision44. This is because
‘it is recognized that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based’.45
Relevant factors in the area of health protection of consumers may consist,
for instance, of societal, economic, traditional, ethical and environmental
factors.46 This approach is in line with the Communication on the
precautionary principle, which indicates that in cases of scientific uncertainty
‘[…] judging what is an ‘acceptable’ risk for society is an eminently political responsibility. Decision-makers faced with an unacceptable risk, scientific uncertainty and public concerns have a duty to find answers’.47
The perceived need to also consider non science-based factors within the
decision-making process characterises the European approach to risk analysis
46 Alberto Alemanno
by differentiating it greatly from the one adopted by US regulatory agencies
and by the WTO/SPS legal framework.48
The EU approach to risk analysis has been effectively described as a
system in which ‘scientific knowledge is authoritative, but not exclusively so’
(Skogstad 2001: 490).
What are the consequences stemming from such a non-exclusively
science-based approach to risk analysis?
The well-know Hormones dispute,49 ‘one of the longest running trade
disputes in the modern trading system’ (Sykes 2006: 260), between the EC
and the US exemplifies the impact that the EC’s particular risk analysis
approach may have, not only on its external trade relations, but also on its
internal market dimension.50 The regulatory regime that was challenged in
this dispute was adopted by the EC institutions notwithstanding the advice of
the Scientific Working group that the banned growth-hormones were
harmless to human health. The ban triggered not only a reaction in the U.S.
and Canadian reactions but also encountered internal resistance.51 Member
States were split over the decision: while France, Germany, Italy and the
Netherlands supported the total prohibition of these growth hormones, the
UK and Ireland opposed it so strongly as to lead to the controversial
legislation being brought before the European Court of Justice.52
The EC ban turned out to be motivated by a complex mix of political,
social, economic and conflicting scientific factors that, as we have seen, may
now formally enter into the EC food decision-making process. Today we
would probably define such a mix of different interests under the ‘collective
preference’ label launched by Pascal Lamy (see Lamy 2004).
Notwithstanding the existence of a scientific consensus concerning a
certain substance, the possibility of taking ‘other legitimate factors’ into
consideration may lead to divisions across Member States over controversial
EU Risk Regulation and Science 47
food safety measures, while at the same time bringing the EC measures into
conflict with the WTO framework.53
The Flaws of the Emerging EU Risk Regulation Framework
The distinction between the purely technical assessment of risks by scientists
and the management of these risks by decision-makers is being increasingly
questioned today.54
The critique takes the form of suggesting that the division is not
credible insofar as it appears to be totally cut off from the concrete reality of
scientific and political work processes (Noiville and De Sadeleer 2001: 408).
Risk assessment cannot be conceived as a wholly objective exercise. Not only
is it influenced by the extensive use of ‘science policies’,55 but also by the
values and beliefs of scientists and the judgments of the profession. In other
words, when dealing with decisions involving technical and scientific aspects,
scientific expertise and political decisions become so intertwined as to
become impossible to separate. In fact, the elaboration of these policies and
assumptions boil down to a risk management activity (Walker 2003: 263).
This entirely legitimate process inevitably leads to stripping the
‘functional separation’ between risk assessment and risk management of its
original goals: the purity of scientific assessment and accountability of risk
managers. These observations suggest that the EC’s dichotomial model of risk
regulation, which has found both institutional and normative expression in
the general food law regulation, fails to normatively recognize the value
judgments implicit in the first stage of risk analysis.56 The risks stemming from
this insistence on the need for a clear-cut separation is that the values and
uncertainties inherent in risk assessment may go unexamined because they do
not formally translate into ‘science policies’. Notwithstanding the growing
rhetoric over transparency in the EC scientific expertise,57 the current
reductionist Community approach to risk analysis does not seem to ensure
48 Alberto Alemanno
that the reasons underlying the decisions are clearly laid out in the policy
choices adopted (judgments, uncertainties and biases in scientific assessment),
thus setting them apart from the scientific results on which they rely, so that
every citizen (and, eventually, the courts) can identify them. To avoid this
and to maintain the original goals pursued by the functional separation
between risk assessment and risk management, it is absolutely imperative not
only to render science policies explicit by furthering the current efforts aimed
at elaborating guidance documents for each EFSA panel,58 but also to clarify
and frame the role played by EC Commission officials attending EFSA
scientific panel meetings.59 In fact, although EFSA is institutionally
independent, there are, however, some tensions arising out of the ‘grey areas’
existing in its relationships with the Commission and from the current
emphasis on the EFSA’s contacts with stakeholders, including industry.60
While the need for industry’s involvement in EFSA’s scientific activities is
questionable, improved participation of consumer groups is already an
indisputable necessity in order to avoid that consumer interests are
overwhelmed by those of industry.
At the same time, it may be advisable to continue the current
Commission’s efforts aimed at harmonising risk assessment procedures within
the Community. In its attempt to develop a harmonised common
methodology for the Scientific Committees activities, the Commission should
improve consistency in the horizontal application of science policies and risk
assessment techniques by developing some robust assessment practices.61 The
Scientific Steering Committee62 advised the Commission to establish a
Working Party on the ‘Harmonisation of Risk Assessment Procedures’ to
specifically address the general principles of risk assessment and their
application to broad consumer health issues, with particular reference to
measures that would enhance compatibility of approaches within the
Scientific Committees. Although it has been recognized that a completely
EU Risk Regulation and Science 49
common methodology for the activities of the Commission Scientific
Committees may not be achievable, it is imperative to avoid the same
chemical, biological or physical agent being dealt with quite differently by the
EFSA panels and the other scientific committees in different contexts,
resulting in potential inconsistency in assessment and confusion in
application.63
The Legal Status and Authority of the Experts’ Opinions (EFSA’s
Scientific Opinions)
The Lack of a Principle of Supremacy of EU Science over National Scientific
Advice
Historically, scientific opinions delivered from any of the different sources of
scientific advice to the Community have not been recognised as legally
binding.64 As a consequence, although the EC institutions are expressly
required to take EFSA’s opinions into account when drafting a Community
measure,65 the Agency lacks formal authority to reach binding resolutions on
potentially contentious scientific issues.66 Therefore, similar to the old
scientific committees and any other European source of scientific advice,67 it
does not have the final word in cases of diverging scientific opinions between
its own decisions and those issued by other bodies. This may be inferred from
Article 30 Regulation 178/2002 (‘the Regulation’) which, while establishing
a procedure aimed at solving problems arising from ‘diverging scientific
opinions’, attributes neither an authoritative nor a mediating role to EFSA,
but simply duties of ‘vigilance’ and ‘cooperation’. This outcome is, at least at
first glance, surprising if analysed in light of the EFSA’s ambition to become
‘the point of reference in risk assessment’ for the whole Community.68 More
precisely, under the Regulation, the Authority is to exercise vigilance in
order to identify at an early stage any potential source of divergence between
its scientific opinions and the opinions issued by national food agencies or
50 Alberto Alemanno
other bodies carrying out similar tasks.69 Where there is a conflict between its
opinion and those of bodies carrying out similar tasks, the EFSA is ‘obliged to
cooperate’70 with the aim of resolving the differences or of presenting a joint
document, which will be made public, identifying the uncertainties and the
‘contentious scientific issues’.71
The introduction of a mere duty of co-operation appears to fall short of
providing an effective answer to the fundamental question as to the
relationships between the European source of expertise and the national
scientific responsible authorities.
By not endowing EFSA opinions with scientific supremacy over
national scientific studies, the Regulation promotes an alternative method of
tackling the issue of diverging scientific opinions between the EFSA and the
national scientific bodies. In order to prevent the emergence of scientific
controversies, EFSA is required to promote European networking of
organisations operating in food safety risk assessment.72 More specifically, the
official aim of such networking is ‘to facilitate a scientific cooperation
framework by the coordination of activities, the exchange of information, the
development and implementation of joint projects, the exchange of expertise
and best practices’.73 In order to facilitate this, the Authority may require
national organisations to provide some preparatory work for scientific
opinions, scientific and technical assistance, some collection of data and
identification of emerging risks.74 This sort of network activity is not without
precedent (Börzel 1998: 253) and it plays a vital role within EFSA’s
operation. In fact, the establishment of this network is necessary in order to
support EFSA’s scientific activities, in particular in conducting scientific
opinions.
EU Risk Regulation and Science 51
The Indirect Legal Effect
Notwithstanding their lack of legally binding nature, the Authority’s opinions
are likely to produce some significant indirect normative effects. In particular,
EFSA’s opinions have the potential to become a source of constraint not only
for the EC institutions, but also for Member States and private parties.
In terms of the EC institutions, the Pfizer Animal Health judgment has
clearly established a general duty to consult the available scientific reports
prepared by experts on behalf of the EC.75 EC institutions are allowed to
depart from this duty only in those exceptional circumstances where
equivalent scientific evidence can be found and a justification for relying on it
is provided. There are therefore good reasons to believe that these constraints
on the possibility of departing from scientific evidence will be maintained by
the EC courts with regard to EFSA’s opinions by transforming them into de
facto authoritative measures. In other words, it is likely that within the new
food safety regime it will be increasingly difficult for the EC institutions to
exercise their discretion beyond the boundaries drawn by a scientific
administrative network led by an independent and authoritative authority
such as EFSA. This is suggested by Directive 1829/2003 governing the
marketing of GMO foods within the EC, where it provides that, should the
Commission decision not be in accordance with an EFSA opinion, the
Commission must ‘provide an explanation for the differences’.76
It is submitted that EFSA’s opinions are likely to acquire some
authoritative value vis-à-vis national decision-makers as well. Although the
Regulation introduces the presumption that, in the absence of specific
Community provisions, all food is deemed to be safe where it complies with
the specific national provisions of the country where it is marketed,77 the
same regulation imposes on Member States the duty to take account of the
results of risk assessment, particularly the opinions of the Authority, when
regulating the food sector. In sum, while domestic authorities are not
52 Alberto Alemanno
procedurally required to consult the EFSA, they are still required to abide by
its scientific opinions in passing new legislation.78 It would therefore seem
impossible for the national authorities to derogate from EFSA’s opinions
without giving some reasons justifying their rejection.
The Authority’s position also has the potential to acquire some legal
significance for private parties. As seen above, the Regulation also imposes a
general obligation on private business operators engaged in production,
processing and distribution to ensure that food placed on the market is safe.79
Any breach of this duty gives rise, at least in principle, to two separate
violations of EC law: a breach of the general obligation to ensure that food is
safe, established by Article 14 of the Regulation, on the one hand, and
violation of the Product Liability Directive on the other (Chalmers 2003:
534). Although national courts are not required to consult the Authority
when investigating such violations, they are likely to rely on its scientific
opinions. In other words, if the EFSA has issued an opinion suggesting that a
product is unsafe, it would be extremely difficult for a private individual to
claim the opposite.
Finally, EFSA’s opinions may also produce legal effects vis-à-vis
national courts. In HLH Warenvertiebs, where the ECJ had expressly been
asked to determine whether the scientific opinions of that Authority may
have binding force on the national courts, it held that
‘[a]n opinion delivered by that Authority, possibly in a matter forming the subject-matter of a dispute pending before a national court, may constitute evidence that that court should take into consideration in the context of that dispute’.80
Notably, the Court has stated that national courts should ascribe to such an
opinion the same value as that accorded to an ‘expert report’.81 Thus, EFSA's
scientific opinions appear susceptible to acquiring a legal status similar to that
of scientific expertise requested by the same national courts of third parties.
EU Risk Regulation and Science 53
Although not binding per se, the scientific report ‘should be taken into
consideration in the context of the dispute’.82
In conclusion, while EFSA’s opinions have not been expressly granted
a direct regulatory authority, they are likely to acquire a de facto legally
binding value for both the EC and the Member States authorities when
passing legislation and amount to a strong probative authority against private
business operators placing unsafe food on the market. More generally, it can
reasonably be expected that EFSA’s opinions will structure the terms of
debate on these issues by influencing enforcement within the Member States
as well as directing public opinion.
Scientific Expertise before Courts
Having illustrated the role played by scientific expertise within decision-
making, the second part of this chapter focuses on how science and science-
based measures are, or may be, judicially reviewed by European courts. In so
doing, it refers primarily to the scientific advice provided within the food
safety area by EFSA.
European Courts and Scientific Opinions
Although the issue as to whether Community courts may review the legality
of the opinions delivered by EC sources of scientific advice is an open
question to the extent that it has not definitively been resolved, it is possible
to make some reasoned suggestions for how it is likely to unfold.
A comparative analysis of the ‘judicial accountability’ of the different
European agencies does not offer any help in developing an answer to the
question of the reviewability of EFSA opinions insofar as their constituent
regulations provide for very different solutions. Thus, for instance, while
some of these regulations explicitly provide that the acts adopted by the
54 Alberto Alemanno
agency are challengeable under Article 230 EC,83 others entrust a specific
chamber of the agency84 or the same Commission85 with the task of
reviewing the legality of the agency’s decisions. In the case of the EFSA, the
general food regulation that establishes that agency does not contemplate the
possibility of submitting its acts to legal review. Rather, a role for EC courts
is envisaged exclusively in the area of contractual and non-contractual liability
of the Authority.86
As a result, the question as to whether EFSA opinions or any other EC
source of scientific advice may be challenged before the European courts is
governed by Article 230 EC.
The application of this provision to scientific opinions raises several
problems. Firstly, Article 230 EC does not contain any reference, either
explicit or implicit, to acts of European agencies or any other scientific
committee or source of expertise.87 It merely refers to the ‘acts adopted
jointly by the European Parliament and the Council, […] acts of the Council,
[…] the Commission and […] the ECB, other than recommendations and
opinions, and […] acts of the European Parliament intended to produce legal
effects vis-à-vis third parties’.88 Moreover, it is difficult to envisage EFSA or
any other source of scientific advice being considered as one of the
institutions or bodies listed therein. Put differently, EFSA decisions or those
coming from external sources do not, strictly speaking, stem from one of
those EC institutions listed in Article 230, paragraph 1, EC.89 Secondly, being
‘preliminary or purely preparatory acts’, scientific opinions would not seem to
fall within the category of acts which can be subject to an action for
annulment, i.e. which covers solely those acts ‘intended to produce legal
effects vis-à-vis third parties’.90 Last but not least, not being addressed to any
individual, scientific opinions could not be assimilated to Community
decisions, but fall within the scope of the forth paragraph of Article 230,
which provide for very demanding standing requirements.91
EU Risk Regulation and Science 55
the risk
assessm
Notwithstanding their non-binding legal nature, it has been established,
with reference to the scientific opinions given by the EMEA’s Committee for
Proprietary Medicinal Products (CPMB), that the opinions are
‘[n]onetheless extremely important so that any unlawfulness of that opinion must be regarded as a breach of essential procedural requirement rendering the Commission’s decision unlawful’.92
In other words, although these scientific opinions do not bind the
Commission, they provide it with the scientific evidence that is necessary to
determine, ‘in full knowledge of fact’, the appropriate measure to ensure a
high level of health protection. Therefore, whenever the scientific opinions
are procedurally vitiated, their unlawfulness will reflect on the subsequent
decision which might be subject to judicial review.
In light of the above, in the Artegodan judgments,93 subsequently
confirmed by the ECJ, the CFI held that EC courts may be called upon to
review the formal legality of an agency scientific committee’s opinion as well
as the Commission’s exercise of its discretion. Although the CFI has stated
that it cannot ‘substitute its own assessment for that of the scientific
committee’, it has held that it may nonetheless review the proper functioning
of the committee, the internal consistency of the opinion and the statement
of reasons contained therein.
Should the Courts extend this approach to EFSA’s scientific opinions,
EC courts might rely on the growing number of guidance documents which
are prepared by the EFSA’s scientific panels in order to define their own
method for conducting risk assessment.94 In fact, these are the only
documents which may potentially provide a useful legality benchmark in
reviewing the proper conduct of the panel when carrying out
ent.
A series of very recent opinions delivered by the CFI seem, however,
to rule out the possibility that EFSA scientific opinions may be judicially
56 Alberto Alemanno
ed by the applicants concerning the nature of the contested acts, it held
tha
ot to be assessed in relation to the requirements of Article 230 EC’.96
easingly called upon to
review measures that are grounded in scientific data.
States
determine the level of intensity of the scrutiny exercised by the EC
courts.
reviewed as such.95 In these decisions, having examined all the arguments
adduc
t
‘[…] the applicant has not prima facie put forward evidence to establish that the Court has jurisdiction to hear and determine actions for annulment challenging EFSA’s acts as such, on the one hand, or to support the conclusion that whether or not EFSA’s acts may form the subject of an action for annulment is n
European Courts and Science-based Measures
While the review of scientific opinions by Community Courts has not
become reality yet, the judicial review of Community science-based measures
already occurs. As scientific evidence is becoming crucial at all stages of the
drawing up of new legislation, EC Courts are incr
The Standard of Judicial Review of Science-based Measures
As seen above, the European scientific discipline has emerged gradually and
quite recently, having first been spontaneously introduced by the Member
States in order to support measures that derogated from EC law. This
introduction of science was then subsequently codified and extended to EC
action in the field of health and environmental protection, notably in the
food safety area. As a result, there is a growing body of science-based case-
law by the European courts dealing with measures adopted by EC Member
and by EC institutions to address risks to health and the environment.
In the absence of an express indication of the standard of review to be
applied to those measures, it is necessary to look at this body of case-law in
order to
EU Risk Regulation and Science 57
At a general level, the EC Treaty, unlike the ECSC Treaty,97 does not
provide any indication as to the standard of review that courts should apply
when scrutinising EC acts. Finding themselves in a normative vacuum, the
European courts filled it by drawing inspiration from the ECSC treaty, which
set forth a rather deferential standard. Thus, in solving a specific legal dispute,
EC courts tend, traditionally, to limit their review to questions of whether
the authorities have or have not used their regulatory discretion in an
arbitrary or unjustifiable manner.98
While the review of EC action is limited in principle to examining
‘whether the exercise of its discretion is vitiated by a manifest error or a
misuse of power’, this standard of review has, through time, been specifically
adapted and shaped so as to apply science-based measures, notably in the food
safety area.
Thus, for instance, when the ECJ was called upon to determine
whether the Commission lacked the competence to adopt Decision 96/239
providing for a total ban on exports of bovine animals, bovine meat and
derived products from the territory of the United Kingdom to the other
Member States and to third countries in the aftermath of the BSE crisis,99 it
declared that
‘[…] since the Commission enjoys a wide measure of discretion, particularly as to the nature and extent of the measures which it adopts, the EC judicature must, when reviewing such measures, restrict itself to examining whether the exercise of such discretion is vitiated by a manifest error or a misuse of powers or whether the Commission did not clearly exceed the bounds of its discretion’.100
Furthermore, it is settled case-law that
‘[…] where a Community authority is required to make complex assessments in the performance of its duties, its discretion also applies, to some extent, to the establishment of the factual basis of its action’.101
58 Alberto Alemanno
This deferential approach to the judicial review of Community measures has
been further elaborated in the Upjohn judgment, which dealt with medicinal
products. Here, the ECJ declared
‘[…] where a Community authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a limited judicial review in the course of which the EC judicature may not substitute its assessment of the facts for the assessment made by the authority concerned. Thus, in such cases, the EC judicature must restrict itself to examining the accuracy of the findings of fact and law made by the authority concerned and to verifying, in particular, that the action taken by that authority is not vitiated by a manifest error or a misuse of powers and that it did not clearly exceed the bounds of its discretion’.102
This deferential standard of review has recently been specifically extended by
the CFI to those situations where Community institutions are
‘[…] required to undertake a scientific risk assessment and to evaluate highly complex scientific and technical facts’.103
Accordingly, in the Bellio case,104 the ECJ upheld the right of the EC to
pursue a policy of ‘zero tolerance’ in regard to the contamination of animal
feed by material that possibly contained the BSE-causing agent, even in
circumstances where the contamination was probably accidental and there
was scientific uncertainty as to the minimum amount of infected material
needed to caused the disease in humans (see Alemanno 2004: 319-323). The
Court came to this conclusion on the basis that that policy had been adopted
‘on the recommendation of experts having at their disposal the relevant
scientific data’ and that it formed ‘part of a coherent body of legislation the
purpose of which is to combat TSEs’.105 By relying on the same deferential
standard of review, the Court has recently overturned, in CEVA, a CFI
finding that the Commission had failed to act to establish a maximum residue
level for progesterone under Regulation 2377/90.106 While the CFI found
EU Risk Regulation and Science 59
that the political and scientific complexity of the progesterone scientific file
‘does not excuse the Commission’s inaction’, the ECJ confirmed that
‘in delicate and controversial cases, the Commission must have a sufficiently broad discretion and enough time to submit for re-examination the scientific questions which determine its decision’.107
Although EC courts have developed different standards of review depending
on whether the health claim stems from the EC or a Member State,108 they
have generally tended, under both standards, not to get involved in the
scientific issues underlying the contested measure and have refrained from
examining the merits and the methodologies of the scientific findings
advanced by the parties.
However, the Pfizer judgment casts some doubts not only on the EC
courts’ traditional deferential approach in reviewing EC science-based
measures,109 but also on its traditional reticence in addressing the scientific
basis of the contested regulations. This judgment has recently been followed
by a line of cases in which the ECJ has shown some willingness to involve
itself more in the technicalities of scientific matters when judicially reviewing
science-based regulations.
The Pfizer Judgment
In this judgment,110 the CFI showed a readiness to become more involved in
the examination of the scientific evidence adduced by the parties to the
dispute, even though the contested measure was of Community origin.111
Immediately following the adoption of an EC Regulation banning the use of
four antibiotics as additives in animal feedstuffs,112 Pfizer, the producer of one
of these antibiotics (virginiamycin), challenged the measure by alleging
manifest errors in the process of risk assessment and a misapplication of the
precautionary principle.
60 Alberto Alemanno
Although the CFI clearly stated from the outset that it was not for it ‘to
assess the merits of either of the scientific points of view argued before it and
to substitute its assessment for that of the Community institutions’, it could
not prevent itself from discussing the scientific validity and merits of the
scientific evidence advanced by the parties. This inevitably led the Court to
engage in a quasi-scientific debate on the main scientific controversy
underlying the legal dispute, i.e. whether there is a link between the use of
virgiamycin as an additive in feedstuffs and the development of streptogramin
resistance in humans. In particular, the Court expressly decided to consider
whether, as maintained by Pfizer, the contested regulation was unlawful
‘because of the inadequate nature of the scientific data’ provided by the
parties. In other words, the Court went so far in its judicial-scientific
involvement as to directly ask itself whether the scientific evidence available
to the EC institutions was ‘sufficiently reliable and cogent for them to
conclude that there was a risk associated with the use of virgiamycin as a
growth promoter’.113
For the first time, an EC Court felt the need to make an express
reference to the quality of the scientific evidence that the EC institutions had
relied upon. Such evidence, so the CFI found, must be ‘sufficiently reliable
and cogent’.114
Before beginning its analysis, the CFI recalled that, due to the complex
assessments of scientific and technical nature behind the challenged regulation
‘[…] judicial review is restricted and does not imply that the Community judicature can substitute its assessment for that of the Community institutions’.115
Notwithstanding this declared limitation, the CFI carried out a detailed
review of the scientific findings brought by the parties so as to determine
whether the EC institutions erred when they concluded, ‘on the basis of the
scientific knowledge available at the time of the adoption of the contested
EU Risk Regulation and Science 61
regulation’, that the use of virginiamycin as an additive in feeding stuffs
entailed a risk to human health. By engaging in a quasi-scientific analysis of
the scientific studies advanced by the parties to the dispute, the Court found
that
‘[…] the Community institutions could reasonably take the view that they had a proper scientific basis for a possible link between the use of virginiamycin as an additive in feeding-stuffs and the development of streptogramin resistance in humans’.116
In other words, the Community was right to take the view that
‘[…] the various experiments and observations […] were not mere conjecture but amounted to sufficiently reliable and cogent scientific evidence’.
The Vitamins Line of Cases
A trend towards greater involvement in scientific debate by the EC courts,
inaugurated in the Pfizer case, appears to have been followed up by a recent
line of cases decided by the ECJ. In this series of cases involving fortified
foods, the Court was called upon to examine four infringement proceedings
brought against Denmark,117 France,118 Italy119 and the Netherlands.120 In
particular, the Commission contested, firstly, the Danish and Dutch practices
of requiring enriched foodstuffs lawfully produced and marketed in other
Member States only to be marketed in their territories if it could be shown
that such enrichment with nutrients meets a need in the Danish and Dutch
populations and, secondly, the French and Italian systems of prior approval
for fortified foods lawfully produced and marketed in other Member States.
In these judgments, the Court established that in order to show that the
national measures are necessary to give effective protection to public health
the competent authorities must base their decisions
‘[…] on a detailed assessment of the risk alleged by the Member State invoking Article 30 EC’.
62 Alberto Alemanno
This detailed scientific requirement had originally been sketched out by the
EFTA Court in the Kellog’s case, where it was established, although within
the EEA context, that Member States must, when invoking the precautionary
principle, conduct a ‘comprehensive evaluation of the risk to health’.121
In reference to the Italian situation the Court found directly that the
Italian government had failed to show ‘any alleged risk to public health’ and
could not ‘explain on what scientific data or medical reports’ it had relied.122
In the case brought against France, the Court found that the scientific
opinions cited by the government were not specific enough to prove the
alleged risk since they refer
‘vaguely to the possibility of a general risk of excessive intake, without specifying the vitamins concerned, the extent to which those limits would be exceeded or the risk incurred’.123
Moreover, in the same French case, the Court found that, contrary to the
studies focusing on L-tarrate and L-carnitine, the studies it relied upon
concerning drinks such as Redbull fulfilled the requested scientific
requirement (‘detailed assessment’) and proved that excessive caffeine content
and the presence of taurine was harmful to human health. On this basis, it
concluded that the Commission had failed to explain or to adduce evidence
to rebut those studies. However, the Court’s opinion simply raises the
question of who is to decide whether the scientific opinion a State relies
upon in the adoption of public health measures is a ‘detailed assessment’
within the meaning of the ECJ’s case law.
This line of cases shows clearly that the Court, by imposing a stricter
scientific assessment process, (a ‘detailed assessment’) seems to be willing to
get involved in scientific matters. Both the CFI (in Pfizer/Alpharma) and the
ECJ (in the Vitamins line of cases) were eager to play with science by
weighing the merits and assessing the validity of scientific opinions set forth
by the parties to the dispute. Both courts have thus inaugurated a new
EU Risk Regulation and Science 63
approach to scientific issues that allows them to ‘pick and choose’ those
scientific opinions they believe better fulfil the minimum scientific
requirements for a measure to be considered as ‘based on a detailed risk
assessment’.
The Role of Scientific Experts before the Courts
Following the Pfizer and Vitamins line of judgments, one may legitimately
wonder whether the EC courts needs a source of external expertise in order
to assess the scientific plausibility of the scientific claims being put forward
both by Member States and EC institutions. There are good reasons to
believe that reliance on such external help might facilitate the role that EC
courts are increasingly called upon to play when reviewing science-based
measures.
Although under the current Statute124 and their respective Rules of
procedure,125 both the CFI and ECJ ‘may at any time entrust any individual,
body, authority, committee or other organizations it chooses with the task of
giving expert opinion’, they have so far been quite reluctant to rely on
external advice. This seems to be especially true for scientific matters. While
the courts, notably the CFI, have ordered expert reports inter alia to assess the
quality of a translator’s work,126 an official's mental state,127 to examine the
rates for and conditions of transport of mineral fuels,128 price rises and the
market in dyestuffs129 and the economic consequences of certain gas tariffs,130
they have rarely done so in scientific matters. Occasionally, the parties have
themselves submitted an expert’s report or, at the hearing, an expert has
addressed the Court on behalf of one of the parties.131
The decision to obtain an expert’s report is made by the Court in the
form of an order after the parties have been given an opportunity to be heard.
The same order appoints the experts, defines the scope of the expertise and
sets a time limit for the drafting of the report.
64 Alberto Alemanno
Despite this rather simple framework for having expertise at its disposal,
EC courts have traditionally been unwilling to use it.
Therefore, before sketching out a possible expertise system within the
EC judicial system, it might be crucial to look at the reasons that have so far
discouraged the EC courts from relying on this possibility. An explanation for
the European courts’ reticence in asking for external advice may be found
within the EC institutional framework itself. One can easily imagine that
where the courts are called upon to review scientific assessments from EC
scientific committees (especially where reviewing a Community measure, for
example), they might feel that submitting one of these studies to a third party
review would amount to questioning both the scientific and institutional
legitimacy of these committees, which ultimately belong to the same system
of governance. However, this argument, which boils down to the idea that
the CFI/ECJ belong to the same institutional family than the Community
legislator, does not seem to be entirely persuasive if examined from a US
perspective. In fact, US Federal Courts do not hesitate to review the risk
assessments undertaken by federal regulatory agencies.132 One can therefore
wonder therefore whether this ‘legitimacy’ argument alone can explain the
EC courts’ deferential attitude vis-à-vis the scientific reports prepared by the
European scientific committees.
A more credible argument for understanding this deferential approach
to science marked by a Europe label refers to judicial tradition. Having
traditionally not relied on scientific expertise, judges (notably the judge
rapporteur in the EC judiciary jargon) might be somehow discouraged from
proposing recourse to expertise under the courts’ rules of procedure to other
Court members. Finally, if tradition plays a crucial part in explaining the
courts’ wariness to rely on scientific experts, fears of ultimately delegating the
task of solving a dispute may also exist.
EU Risk Regulation and Science 65
In attempting to develop a credible and effective expert consultation
system for EC courts when dealing with scientific matters, it is important to
take due account of the institutional scientific framework upon which the
Community relies when adopting legislation.
Unlike the WTO’s judicial bodies, the European courts, when called
upon to review a science-based measure, are likely to already have a scientific
study supporting that measure or, at least, dealing with its scientific
foundations. While this is certainly the case when the courts are called upon
to examine the legality of an EC measure, it might not be the case when the
contested regulation has been adopted by a Member State. In the latter case,
the national measure is supported instead by a national scientific opinion
produced by its own authorities.
Against this backdrop, one may wonder what body might be available
for consultation by the EC courts to examine the scientific adequacy of the
evidence brought by the parties to the dispute. Should they ask the EC
scientific committee members, perhaps those sitting within EFSA, to review
the evidence they have themselves developed? Or should they rely on some
third-party scientists? And quid in cases of science-based national measures?
Should the Court submit the national scientific evidence to the scrutiny of
the EC scientific committees?
It is extremely difficult to answer this very last question as there is no
hierarchy between research bodies and their scientific advice. It is therefore
problematic to see how, in the event of conflicting scientific studies, it could
be justified to follow one set of scientific opinions rather than another.
Peer Review as an Alternative Method to External Expertise
A valid alternative method to external expertise might be represented by
reliance on peer review.133 This is a formal science-based process that is
traditionally used when a scientific work is nearly complete, and utilises
66 Alberto Alemanno
independent experts who were not involved in the development of the
scientific study.
Although it is used primarily by publishers to select and screen
submitted manuscripts,134 and by funding bodies, to decide the awarding of
research funding, the peer review process is also utilised for risk assessment
procedures. In these circumstances, it involves an in-depth assessment of the
assumptions, calculations, alternate interpretations, methodology and
conclusions. In particular, by taking the form of a deliberation, it involves an
exchange of judgments about the appropriateness of methods and the strength
of the author’s inferences.135
The practice of peer review of risk assessment products is not entirely
unknown in the Community or in the WTO. Thus, for instance, within the
framework of the European directive on the placing of plant protection
products on the market, EFSA has launched a peer review of the assessments
made by Member States with the aim of creating a ‘positive list’ of
pesticides.136
It is thus suggested that, like decision-makers, courts can also rely on
peer review, by either asking experts to peer review the scientific evidence
advanced by the parties or by simply showing deference to that evidence
whenever it has been subject to peer review.
One of the main advantages stemming from judges’ reliance on peer
review is that, via this tool, they might determine the exact scope of experts’
review, by, for instance, asking them to distinguish scientific facts from
professional (science policies) judgments.
This might turn out to be especially useful in the current EC risk
analysis framework, which does not recognise that uncertainty is inherent in
science and that in many cases scientific studies do not produce conclusive
evidence.
EU Risk Regulation and Science 67
In particular, it is suggested that proof of a prior peer review must give
rise to a presumption of conformity of that evidence with the relevant
scientific evidence. However, prior peer review is not by itself sufficient
ground for triggering such a presumption. There is clearly a need for some
evidence proving the adequacy of prior peer review. Thus, for instance,
publication in an important scientific journal may mean that adequate peer
review has been performed.
An example of such a deferential approach to peer reviewed scientific
evidence may be seen in Methanex,137 a recent case decided by the North
American Free Trade Agreement’s NAFTA Tribunal under the provisions in
the NAFTA Chapter 11 on investment and the UNCITRAL arbitration
rules.138 At the heart of this case was an investment dispute between the
Canadian-based Methanex Corporation and the United States. Methanex is a
major producer of methanol,139 a gasoline additive that was banned by
California in 2002 on environmental and human health grounds. Methanex,
having submitted a claim to NAFTA, argued, inter alia, that the ban was not a
genuine environmental measure but a disguised restriction of trade.140 In
replying to this argument, the NAFTA Tribunal, ‘having considered all the
expert evidence adduced’, accepted the scientific evidence underpinning the
contested measure ‘as reflecting a serious, objective and scientific approach to
a complex problem in California’. In particular, the Tribunal came to this
conclusion by taking account of the fact that this scientific evidence ‘was
subject at the time to public hearings, testimony and peer-review’. In light of
the above, it concluded that
‘its emergence as a serious scientific work from such an open and informed debate is the best evidence that it was not the product of a political sham engineered by California’.141
I believe that there is a great deal to be learned from this use of peer-review
within the EC judicial review of science-based measures and that, if well-
68 Alberto Alemanno
tuned, it might even represent a valuable alternative to expert consultation
mechanisms.
Conclusion
Despite the flaws and limitations that we have highlighted, the emerging risk
regulatory framework, by denying any supremacy to the EC sources of
scientific opinions over national advice, preserves Member States’ rights to
carry out their own scientific studies and even strengthens their roles through
the establishment of the European networking of scientific authorities. In
particular, it is argued that the deliberate choice not to turn EFSA into an
Oracle of Delphi, spelling out the ‘truth’ in all scientific matters, while likely
to bring about conflicts among Member States, may be seen as an attempt to
reconcile science, traditions, consumer concerns and free movement.
Accordingly, in cases of diverging opinions between the EFSA and national
food authorities, it is up to the EC courts, and not to EFSA, to solve these
conflicts by striking a balance between the European (universal) and a
national (local) vision of both safety and of the socio-cultural perception of a
particular food (Chalmers 2003: 534). Furthermore, the EC risk management
policy, which allows risk managers to take into account ‘other factors
legitimate to the matter under consideration’ and the precautionary principle
in addition to hard scientific opinions142 must be applauded to the extent that
it embraces the political nature of risk regulation. However, to maintain the
original goals pursued by the functional separation between risk assessment
and risk management, it is absolutely imperative to render science policies
explicit by furthering the current efforts aimed at elaborating guidance
documents for each EFSA panels.143
As to the role played by scientific expertise before courts within the
emerging European regulatory framework, it has been illustrated that
EU Risk Regulation and Science 69
scientific opinions, as non-legally binding acts but rather mere preparatory
acts, do not seem susceptible of judicial review as such. However, as scientific
evidence is becoming crucial at all stages of the creation of new legislation,
EC Courts are increasingly called upon to review science-based measures. In
so doing, Courts have generally avoided becoming enmeshed with scientific
evidence by showing great deference to the technical and complex
assessments underpinning the contested measures. However, some recent
cases show a readiness of the Courts to become more involved in the
examination of the scientific evidence presented, even where the contested
measure has a Community origin. To mitigate partly the difficulties faces by
the Courts in performing this difficult task it has been suggested that they
should rely primarily on peer-review mechanisms rather than on external
consultation procedures.
Notes
1 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January
2002 laying down the general principles and requirements of food law, establishing the
European Food Safety Authority and laying down procedures in matters of food safety, OJ
2002 L 31 (hereinafter: the Regulation). 2 See, e.g., Council Directive 1999/30/EC of 22 April 1999 relating to limit values for sulphur
dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air (OJ
L 163) and Directive 2001/80/EC of the European Parliament and of the Council of 23
October 2001 on the limitation of emissions of certain pollutants into the air from large
combustion plants (OJ L 309). 3 Risk assessment of existing chemicals is provided by Council Regulation (EEC) 793/93 (OJ
L 84) and Commission Regulation (EC) 1488/94 (OJ L 161). As for new chemicals, risk
70 Alberto Alemanno
assessment procedures are imposed by Commission Directive 93/67/EEC of 20 July 1993
laying down the principles for assessment of risks to man and the environment of substances
notified in accordance with Directive 67/548/EEC, OJ L 227. See also CEC, Commission of
the European Communities, Proposal for a Regulation of the European Parliament and of the Council
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing
a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on
Persistent Organic Pollutants) COM(2003) 644 final, 29 October 2003, Brussels. 4 Directive 98/08/EC concerning the placing of biocides on the market, OJ L 150, p. 71. 5 See Articles 4(1) and (2) of Directive 2001/18/EC of the European Parliament and of the
Council of 12 March 2001 on the deliberate release into the environment of genetically
modified organisms and repealing Council Directive 90/220/EEC, OJ L 106. Moreover,
under Article 8 of the Regulation (EC) No 258/97 of the European Parliament and of the
Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43), a
novel food or food ingredient is considered to be “equivalent” to its conventional counterpart
unless established risk assessment techniques can prove that this is not the case. 6 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection
products on the market, OJ L 230, p. 1-32. See also the 1998 Rotterdam PIC Convention
which requires a “risk evaluation” as a precondition for regulatory action. 7 Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of
the Member States concerning food additives authorizd for use in foodstuffs intended for
human consumption (OJ L 40) according to which the food additive must be subjected to
appropriate testing and evaluation. 8 See Article 16(2) of Directive 2000/60/EC of the European Parliament and of the Council of
23 October 2000 establishing a framework for Community action in the field of water policy,
OJ L 327. 9 Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from
the risks related to exposure to chemicals, physical and biological agents, OJ L 327/8; Council
Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage the
improvements in the safety and health of workers at work, OJ L 183; Council Directive
90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure
to carcinogens at work, OJ L 196. 10 While Article 28 prohibits Member States adopting quantitative restrictions on imports and
all measures having an equivalent effect to a quantitative restriction, Article 30 “shall not
preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds
of public morality, public policy or public security; the protection of health and life of humans,
EU Risk Regulation and Science 71
animals or plants; the protection of national treasures possessing artistic, historic or
archaeological value; or the protection of industrial and commercial property”. 11 Case 178/84, Commission v. Germany [1987] ECR 1227. 12 According to the Reinheitsgebot (the German beer purity law), originally enacted in 1516
by the Bavarian duke Wilhelm IV, only beer containing the following ingredients could be
marketed on the German territory: water, hops, barley, and yeast. 13 Case 178/84, Commission v. Germany [1987] ECR 1227, para 48. 14 Case 174/82, Sandoz BV [1983] ECR 2445, para 214. In this case, the Court had to face a
Dutch refusal to grant authorization for the importation of muesli bars with added vitamins
from Germany (where they were lawfully sold). For a comment on this case, see Slotboom
2003: 557. 15 Case 247/84 Motte [1985] ECR 3887. This case concerned the import of lumpfish roe
prepared with colorants banned in Belgium but allowed in the country of export. 16 Case 304/84 Ministère Public v. Muller and others [1986] ECR 1511. 17 Case 178/84 Commission v. Germany [1987] ECR 1227, para 44. 18 Case C-42/90 Bellon [1990] ECR 4863, at 14. 19 Case C-13/91 and C-113/91 Debus [1992] ECR 3617, at 17. 20 In KYDEP, involving the Community rules governing the maximum levels of radioactive
contamination permissible in foodstuffs following the Chernobyl nuclear accident, the ECJ has
even referred not only to “the opinions of national experts on radioactivity and foodstuffs, the
recommendations of the International Commission on Radiological Protection (ICRP)” but
even to “the instructions of the US Food and Drug Administration”. See Case C-146/91
Koinopraxia Enóséon Georgikon Synetairismon Diacheiríséos Enchorion Proïonton Syn. PE
(KYDEP) v. Council and Commission [1994] ECR 4199, at 42. 21 According to Article 95, paragraph 5, “if, after the adoption by the Council or by the
Commission of a harmonisation measure, a Member State deems it necessary to introduce
national provisions based on new scientific evidence relating to the protection of the
environment or the working environment on grounds of a problem specific to that Member
State arising after the adoption of the harmonization measure, it shall notify the Commission of
the envisaged provisions as well as the grounds for introducing them”. 22 Although a similar scientific requirement is not expressly provided for with reference to the
situation in which a Member State does maintain a measure derogating from a harmonized
measure (Article 95, paragraph 4), it may reasonably be argued that a scientific requirement is
also de facto imposed within the context of the application of paragraph 4 of Article 95. See
Alemanno 2007a: 300.
72 Alberto Alemanno
23 Article 174, paragraph 3, EC. 24 See Article 174, paragraph 2, EC. 25 Article 100a(3) of EC, current Article 95, paragraph 3. 26 Article 95, paragraphe 3, EC. See also, Articles 152 (1) and (4), 153, 174 (2). 27 CEC, Commission of the European Communities, Communication from the Commission on
consumer health and food safety, COM(97) 183 final, 30 April 1997, Brussels. 28 Ibid. 29 See Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees
in the field of consumer safety, public health and the environment, OJ L 66, recital 6 of the
Preamble. 30 Communication from the Commission on Consumer Health and Food Safety, supra note 27,
and CEC, Commission of the European Communities, Communication on the precautionary
principle, COM(2000) 1, 2 February 2000, Brussels. 31 Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community
procedures for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Agency for the Evaluation of Medicinal Products,
OJ L 214. 32 Commission Decision 2004/210/EC, supra note 29, pp. 45-50. There are three committees:
Scientific Committees on Consumer Products (SCCP); Scientific Committee on Health and
Environmental (SCHER) and Risks Scientific Committee on emerging and Newly Identified
Health Risks (SCENIHR). To coordinate these committees an Inter-Committee, made up of
the Chairs and Vice-Chairs of the three Committees, has been established. Its main task is to
assist the Commission on matters relating to the harmonisation of risk assessment. In addition,
it deals with questions which are common to more than one Committee, diverging scientific
opinions and exchange of information on the activities of the Committees. 33 CEC, Commission of the European Communities, COM(2002) 713 final, 11 December
2002, Brussels. 34 Commission Decision 2004/210/EC, supra note 29, p. 45. 35 Whenever the Commission departments collect and use the advice of experts from outside
the responsible department they should ensure quality, by seeking advice from an appropriately
high quality source (i.e. based on the principles of excellence, independence and pluralism), by
showing flexibility when looking for advice, and effectiveness, by making sure that its methods
for collecting and use of expert advice are effective. 36 According to the Updated Opinion of the Scientific Steering Committee on Harmonization
of Risk Assessment Procedures, adopted on 10-11 April 2003, a full Second Report on the
EU Risk Regulation and Science 73
Harmonization of Risk Assessment Procedures is currently being editing and will be published
shortly (sic!). 37 For decades the National Research Council (NRC) has been called on to consider how to
improve decisions about risks to public health, safety and environmental quality. The NRC
has conducted a series of studies on how society can understand and cope with those risks. In
particular, the distinction between risk assessment and risk management was originally
conceived in 1983 with the publication of Risk Assessment in the Federal Government: Managing
the Process (also called the Red Book), a study that sought "institutional mechanisms that best
foster a constructive partnership between science and government". Subsequently, this
distinction played a crucial role in the development of an organizational separation of risk
assessment and risk management in many US regulatory agencies. However, as we will see
further, later publications of the NRC recognized the difficulties of maintaining a sharp
dividing line between the two processes and emphasized the importance of ensuring
interaction and communication between risk assessors and risk managers. See Stern and
Fineberg 1996 and for a brief account of this development see also Suezenauer, Tamplin,
Buchanan, Dennis, Tollefson and Hart 2003. 38 See, within the U.S., National Academy Press 1994: 4 (prepared by a Committee of the
National Research Council/National Academy of Science in response to a U.S.
Environmental Protection Agency request mandated by the Clean Air Act Amendments of
1990); see, within the OECD 2003; see within FAO/WHO 1995:6; Joint FAO/WHO
(1997); Joint FAO/WHO (1998). 39 This separation was originally introduced by the 1997 Communication on Consumer Health
and Safety, supra note 27, and subsequently confirmed by the CEC, Commission of the
European Communities, Green Paper on Food Law, COM(97) 176 final, 30 April 1997, and the
White Paper on Food Safety, COM(99) 719, 12 January 2000, para 32. 40 Among the major drivers for this separation was a clear desire to remove value judgments
from risk assessment and to prevent risk assessors from being unduly influenced by risk
managers. 41 According to the Commission's White Paper, the EFSA should not be entrusted with risk
management tasks because this would reduce democratic accountability within the Union,
supra note 39, at 32. 42 Opinion in Case 192/01 Commission v. Denmark [2003] ECR 9693. 43 Case T-13/99 Pfizer Animal Health v. Council [2002] ECR II-3305, at 157. See already
Case 212/91, Angelopharm v. Freie Hansestadt Hamburg [1993] ECR I-171, paras 31-33.
74 Alberto Alemanno
44 Several provisions of the Regulation provide that risk management decisions may consider
not only risk assessment but also “other legitimate factors”. See preamble (19), Article 3 (12)
and Article 6 (3). See also, e.g., Article 7(1) of Regulation (EC) No 1829/2003 of the
European Parliament and of the Council of 22 September 2003 on genetically modified food
and feed, OJ L 287. 45 The Regulation, supra note 1, Recital (19). 46 The list of examples provided by the Preamble of the Regulation seems slightly narrower
than that contained within the White Paper (see supra note 39, para 4), which mentions
“environmental considerations, animal welfare, sustainable agriculture, consumers’ expectation
regarding product quality, fair information and definition of the essential characteristics of
products and their process and production methods”. However, as both lists contain only mere
examples, their differences do not carry any particular value and should not be overemphasised. 47 Commission Communication on the precautionary principle, supra note 30, at 5 of the
summary. 48 For a comparison between the EC and WTO risk analysis schemes, see Alemanno 2007a:
387 ss. 49 See Appellate Body Report, European Communities - Measures Concerning Meat and Meat
Products, WT/DS26/AB/R, WT/DS48/AB/R (January 16, 1998) (adopted February 13,
1998; Panel Report, European Communities - Measures Concerning Meat and Meat
Products, WT/DS26/R/USA (August 18, 1997) (hereinafter: EC-Hormones). For a detailed
reconstruction and insightful analysis of the dispute, see Christoforou 2003: 239 and Wüger
2002: 777. 50 On this dispute, notably on its genesis, see, e.g., Christoforou 2000: 622 ss.; Scott 2000;
Pardo Quintillán 1999: 147; Howse 2000: 2329. 51 Thus, for instance, an association of pharmaceutical manufacturers sought the annulment of
the Directive prohibiting the use of certain hormonal growth promoters for the purpose of
fattening cattle. See Case 160/88 Fedesa v. Council [1988] ECR 6399. 52 Case C-180/96, United Kingdom v. Commission [1998] ECR 3903, at 93. See also Case C-
157/96, The Queen v. Ministry of Agriculture, Fisheries and Food, ex parte National Farmers’
Union et al. [1998] ECR I-2211. Contrary to the former case, the latter was not a direct
action for annulment of the EC ban, but rather a preliminary ruling pursuant to a question
about the validity of the EC measure from the UK High Court. 53 This Agreement subjects all sanitary and phytosanitary measures to scientific evidence and
risk assessment procedures by imposing on Member States the duty to demonstrate that their
measures are necessary to protect human health. Under the existing SPS Agreement, scientific
EU Risk Regulation and Science 75
evidence is, at least textually, the only legitimate criterion upon which to base SPS measures.
For more on the WTO/SPS framework, see Alemanno 2007a: 227-290. 54 This distinction has been criticised for being artificial and difficult to maintain in reality. For
a European perspective, see Noiville and De Sadeleer 2001: 406-408; and, more, recently,
Ladeur 2003: 1465. For a U.S. perspective, see Walker 2003: 252 and Wirth 1994: 833-834. 55 These may be defined as “decision rules about the way in which risk assessment scientists
should proceed when they encounter specified types of uncertainties”, which are established at
political level. See Walker 2003: 214. One of the most common science policies is the
presumption that a certain agent that can cause disease in laboratory animals can equally cause
disease in humans. Other examples include the use of a linear dose-response model, the
assumption that absorption in animals and humans is approximately the same or the use of
body weight scaling for interspecies comparisons. 56 It is argued that in the EC food context, where the question of science policies has not
specifically been addressed at regulatory level, the European Food Safety Authority is never
simply conveying information, but is inevitably endorsing a particular ideological model of
politics. Along these lines of thought, see Chalmers 2003: 543. 57 CEC, Commission of the European Communities, European Governance: A White Paper,
COM(2001) 428 final, 25 July 2001, Brussels; CEC, Commission of the European
Communities, Communication on the Collection and Use of Expertise by the Commission: Principles
and Guidelines, COM(2002) 713 final, 11 December 2002, Brussels; CEC, Commission of the
European Communities, The Operating Framework for the European Regulatory Agencies,
COM(2002) 718 final, 11 December 2002, Brussels. 58 Most of the EFSA scientific panels are in the process of adopting guidance documents aimed
at establishing a method for conducting risk assessment. Thus, for instance, the Scientific Panel
on Genetically Modified Organisms has adopted a Guidance document for the risk assessment
of genetically modified microorganisms and their derived products intended for food and feed
use (The EFSA Journal (2006) 374, 1-115 Summary) and also a Guidance document for the
risk assessment of genetically modified plants and derived food and feed (the EFSA Journal
(2004) 99, 1-94). 59 Although officials’ attendance is subject to the condition that they “shall not seek to
influence discussions”, it is likely that their mere presence at the meetings may in some cases
influence the delivery of scientific opinions. Thus, the scientists, depending on the
circumstances, may be inclined to deliver the anticipated opinion or they may fail to take due
account of some scientific information available to them. According to Greenpeace, the latter
has already happened in EFSA’s assessment of the first two genetically engineered crops
76 Alberto Alemanno
submitted to its examination. Greenpeace has severely criticised European scientists for having
ignored two critical scientific factors. See Alemanno 2007a: 213-215. 60 For more on the relationship existing between EFSA and the Commission, see Gabbi 2007:
131 and Alemanno 2007b: 610-611, 627-629. 61 A recent initiative has been launched by the European Consumer Safety Association
(ECOSA) on the occasion of the Edinburgh Risk Assessment Conference. A working party
has been established with the aim of developing a common nomenclature for risk assessors and
a more standardised framework for the actual risk assessment process. 62 The European Commission decided on 10 June 1997 to create a Scientific Steering
Committee (SSC) in the field of consumer health and food safety. The detailed mandate of this
Committee is available at <http://ec.europa.eu/food/fs/sc/ssc/index_en.html>. 63 Updated Opinion of the Scientific Steering Committee on Harmonisation of Risk
Assessment Procedures, adopted on 10 April 2003, at 2. 64 Case 247/84 Motte [1985] ECR 3887, para 20, in which the Court said that Member States
must “take into account” the results of international scientific research, but where it also stated
that “it must be emphasised that the Opinions of the Committee do not have binding force”. 65 The Regulation, supra note 1, Article 22 (6). 66 This conclusion deserves to be further elaborated by reference to those situations in which
EFSA risk assessment is required by EC vertical legislation. In these circumstances, EFSA
opinions enjoy the express status recognised by the legislation. Thus, for instance, under the
GMO pre-market approval system, where the Commission decision is not in accordance with
the EFSA opinion, the Commission must provide an explanation for the differences. See
Article 7 of Regulation 1829/2003, supra note 44 (which reads: “[…] where the draft decision
is not in accordance with the opinion of the Authority, the Commission shall provide an
explanation for the differences”). See on this point Krapohl 2004: 532. 67 Case 247/84 Motte [1985] ECR 3887, para 20, where the Court said that Member States
must “take into account” the results of international scientific research, but it also stated that
“it must be emphasised that the Opinions of the Committee do not have binding force”. 68 The Regulation, supra note 1, Preamble (34) and (47), Article 22 (7). 69 The Regulation, supra note 1, Article 30 (1). 70 Although it is not expressly provided within the Regulation, this duty of cooperation must
be read in light of Article 10 of the EC Treaty. 71 The Regulation, supra note 1, Article 30 (3-4). This system recalls the compulsory
notification system of draft technical regulations to the extent that it functions as a preventive
EU Risk Regulation and Science 77
mechanism (sort of ‘early-warning’) aimed at solving ex ante any conflict arising between the
national and European views of risk. 72 The Regulation, supra note 1, Article 36 of the Regulation titled “Networking of
organisations operating in the fields within the Authority's mission”. 73 The Regulation, supra note 1, Article 38. 74 Article 4 of Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying
down detailed rules for the implementation of European Parliament and Council Regulation
(EC) No 178/2002 with regard to the network of organisations operating in the field within
the European Food Safety Authority’s mission, OJ L 379. Under the same regulation, Member
States are required to forward to the Authority, with a copy to the Commission, the names
and details of the designated organisations, evidence that they comply with the criteria set out
by Regulation 2230/2004 and details of their specific fields of competence. 75 Case T-13/99 Pfizer Animal Health v. Council [2002] ECR II-3305. See also the parallel
case T-70/99 Alpharma v. Council [2002] ECR II-3495. 76 See Article 7 of Regulation 1829/2003, supra note 44. 77 The Regulation, supra note 1, Article 14 (9). 78 The Regulation, supra note 1, Article 6 (3). 79 The Regulation, supra note 1, Article 14 (1). 80 Cases C-211/03, C-299/03 and C-316/03 to C-318/03, HLH Warenvertriebs GmbH
[2005] ECR 5141, at 94. 81 Ibid., at 93. 82 Ibid., at 94. 83 Article 17 of Council Regulation (EEC) No 302/93 of February 1993 on the establishment
of a European Monitoring Centre for Drugs and Drug Addition, OJ L 36, p. 1. This provision
clearly states that "the Court of Justice shall have jurisdiction in actions brought against the
Centre under the conditions provided for under Article 173 [now 230] of the Treaty". See also
Article 15(3) of Council Regulation (EC) No 1035/97 of 2 June 1997 establishing a European
Monitoring Centre on Racism and Xenophobia, OJ L 151, p. 1. 84 Articles 57 and 63 of Council Regulation (EC) No 40/94 of 20 December 1993 on the
Community trade mark, OJ L 11, p. 1. 85 This is the case, for instance, of the Community Plant Variety Office (CPVO) as established
by Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights,
OJ L 227, p. 1. 86 According to the Regulation, supra note 1, Article 47: “1. [t]he contractual liability of the
Authority shall be governed by the law applicable to the contract in question. The Court of
78 Alberto Alemanno
Justice of the European Communities shall have jurisdiction to give judgment pursuant to any
arbitration clause contained in a contract concluded by the Authority. 2. In the case of non-
contractual liability, the Authority shall, in accordance with the general principles common to
the laws of the Member States, make good any damage caused by it or its servants in the
performance of their duties. The Court of Justice shall have jurisdiction in any dispute relating
to compensation for such damage. 3. The personal liability of its servants towards the
Authority shall be governed by the relevant provisions applying to the staff of the Authority”. 87 Article 230 EC Treaty, paragraph 1, reads: “[t]he Court of Justice shall review the legality of
acts adopted jointly by the European Parliament and the Council, of acts of the Council, of the
Commission and of the ECB, other than recommendations and opinions, and of acts of the
European Parliament intended to produce legal effects vis-à-vis third parties”. 88 This obstacle would per se not appear insurmountable to the extent that the ECJ, in the past,
has shown itself to be ready to interpret broadly the category of acts reviewable under Article
230 EC. See Case 294/83, Les Verts v. Parliament, ECR 1986, p. 1339 and Case 193-4/87,
Maurissen v. Court of Auditors, ECR 1989, p. 1045. In these judgments the ECJ considered
that insofar as the Community is based on the rule of law, acts not mentioned in Article 230
EC are also capable of forming the subject of an action for annulment. 89 It is precisely by relying on this argument that the CFI, in Associazione delle cantine sociali
venete, declared inadmissible an action for a failure to act directed against the European
Ombudsman. Case T-103/99 Associazione delle cantine sociali venete v. Médiateur européen
and Parliament [2000] ECR II-4165, paras 44-48. For a detailed analysis and comment of this
judgment, see Raimondi 2004: 547 ss. 90 Case 60/81 IBM v. Commission [1981] ECR 2639, paras 9-10 and order of 24 March 2006
in Case T-454/05 R Sumitomo Chemical AGRO Europe and Philagro France v.
Commission, not published in the ECR, paragraph 50. 91 Under Article 230 EC, judicial persons can easily challenge the legality of Community
decisions when these decisions are addressed to them. However, the same article provides for a
very demanding locus standi requirement where the act challenged is not a decision. Under the
fourth paragraph of Article 230 EC, an individual may institute proceedings against other acts
only when these are "of direct and individual concern". 92 Joined Cases T-144/00, T-76/00, T-83/00, T-84/00, T-85/00, T-132/00 and T-141/00
Artegodan a.o. v. Commission [2002] ECR II-4945, at 197. 93 Joined Cases T-144/00, T-76/00, T-83/00, T-84/00, T-85/00, T-132/00 and T-141/00
Artegodan a.o. v. Commission [2002] ECR II-4945.
EU Risk Regulation and Science 79
94 Thus, for instance, the Scientific Panel on Genetically Modified Organisms has adopted a
Guidance document for the risk assessment of genetically modified microorganisms and their
derived products intended for food and feed use (The EFSA Journal (2006) 374, 1-115
Summary) as well as a Guidance document for the risk assessment of genetically modified
plants and derived food and feed (the EFSA Journal (2004) 99, 1-94). 95 Orders of the President of the CFI delivered on March 1, 2007, Case T-397/06 R Dow
AgroSciences Ltd v. EFSA and Cases T-311/06 R I, T-311/06 R II, T-312/06 R I and T-
313/06 R FMC Chemical SPRL, Arysta Lifesciences SAS and Otsuka Chemical Co. Ltd, not
yet reported. 96 Dow AgroSciences, supra note 95, at 39. 97 Article 33(1) of the European Coal and Steel Community reads: “[…] The Court of Justice
may not, however, examine the evaluation of the situation, resulting from economic facts or
circumstances, in the light of which the Commission took its decisions or made its
recommendations, save where the Commission is alleged to have misused its powers or to have
manifestly failed to observe the provisions of this Treaty or any rule of law relating to its
application”. 98 This is settled case law. See, in particular, in the competition law field, Joined Cases 56/64
and 58/64 Consten and Grundig v. Commission [1966] ECR 299, at page 347; in the
agricultural field, Case 55/75 Balkan-Import Export v. Hauptzollamt Berlin-Packhof [1976]
ECR 19, at 8 and Case 98/78 Racke v. Hauptzollamt Mainz [1979] ECR 69, para 5; Case
265/87 Schräder [1989] ECR 2237, para 22; Joined Cases C-267/88 to C-286/88 Wuidart
and Others [1990] ECR I-435, para 14; Case C-331/88 Fedesa and Others [1990] ECR I-
4023, at 14; Case C-157/96 National Farmers' Union and Others [1998] ECR I-2211, at 39;
in the civil servants case law, Case 9/82 Øhrgaard and Delvaux v. Commission [1983] ECR
2379, at 14; in the state aid field, Case C-225/91 Matra v. Commission [1993] ECR I-3203, at
24-25. However, it should be noted that in the field of competition law the CFI has recently
shown that it was ready to perform an in-depth analysis of the Commission’s decisions. See for
instance, the Babyliss case, T-114/02 [2003] ECR II-1279. 99 Decision 96/239/EC of 27 March 1996 on emergency measures to protect against bovine
spongiform encephalopathy,OJ L 78. 100 Case C-157/96, National Farmers' Union and Others [1998] ECR I-2211, para 39;
referring to Case 98/78 Racke v. Hauptzollamt Mainz [1979] ECR 69, para 5. 101 Case 138/79 Roquette Frères v. Council [1980] ECR 3333, para 25; Joined Cases 197/80
to 200/80, 243/80, 245/80 and 247/80 Ludwigshafener Walzmühle v. Council and
Commission [1981] ECR 3211, para 37; Case C-27/95 Bakers of Nailsea [1997] ECR I-1847,
80 Alberto Alemanno
para 32; Case C-4/96 Nifpo and Northern Ireland Fishermen's Federation [1998] ECR I-681,
paras 41 and 42; Case C-120/97 Upjohn [1999] ECR I-223, para 34; and Spain v. Council,
cited at para 115 above, para 29 and, lastly, T-13/99, Pfizer, supra note 75, at 168. 102 See Case C-120/97, Upjohn Ltd [1999] ECR 223, para 34. See, also, Case C-405/92
Mondiet [1993] ECR 6133. See, for a similar statement, in the competition law field, Joined
Cases 56/64 and 58/64 Consten and Grundig v. Commission [1966] ECR 299, at page 347.
See, in particular, the most recent interpretation of this judgment in Case C-168/01
GlaxoSmithKline Services Unlimited v. Commission [2006] not yet reported, at 241 where it
is said that: "the Court dealing with an application for annulment of a decision applying Article
81(3) EC carries out, in so far as it is faced with complex economic assessments, a review
confined, as regards the merits, to verifying whether the facts have been accurately stated,
whether there has been any manifest error of appraisal and whether the legal consequences
deduced from those facts were accurate". 103 See Case T-13/99 Pfizer Animal Health v. Council [2002] ECR II-3305, paras 168-69 and
323. 104 Case C-286/02 Bellio F.lli Srl v. Prefettura di Treviso [2004] not yet reported. 105 Case C-286/02 Bellio F.lli Srl v. Prefettura di Treviso [2004], para 61. 106 Case C-198/03 P, Commission v. Ceva/Pfizer [2005], not yet reported. 107 Ibid., at 75. 108 While the EC judiciary shows itself to be quite deferential in examining the EC's efforts to
attain a high level of protection of health, through the adoption of food (and feed) safety
regulations, when it comes to the Members States' use of science in pursuing health protection
goals, it adopts a more intrusive approach. In particular, the Courts are demanding in assessing
whether the contested measure is adequately backed up by credible scientific evidence. For a
possible explanation of this phenomenon, see Alemanno 2007a: 325-336. 109 Case T-13/99 Pfizer Animal Health v. Council [2002] ECR II-3305. 110 See also the parallel case that concerned the same decision, revoking the authorization of
some antibiotics as growth promoters: T-70/99, Alpharma Inc. v. Council [2002] ECR II-
3495. For a comment on these two judgments, see ex multis, Walker 2003: 207-208; Vos 2004;
Mariatte 2002: 12; Gonzalez Vaqué 2002: 925, n. 13 and Alemanno 2002: 842. 111 Contra, see Peel 2004: 43 who argues that "Although the Court stressed that regulatory
authorities must have at their disposal scientific information which is sufficiently reliable and
cogent to allow them to understand the ramifications of the scientific questions raised and to
make a decision on policy measures in full knowledge of the facts, the CFI displayed a
EU Risk Regulation and Science 81
“strongly deferential attitude when reviewing the institutions’ interpretation of the scientific
material and their judgments as to the existence of genuine scientific uncertainty". 112 These antibiotics were used as growth promoters, with the useful side effect of preventing
certain animal diseases. 113 Case T-13/99 Pfizer Animal Health v. Council [2002] ECR II-3305, at 322. 114 Ibid., para 162. 115 Ibid., para 323. 116 Ibid., para 393. 117 Case 192/01 Commission v. Denmark [2003] ECR 9693. 118 Case C-24/00 Commission v. France [2004] ECR I-1277. 119 Case C-270/02 Commission v. Italy [2004] ECR I-1559. 120 Case C-41/02 Commission v. Netherlands [2004] ECR I-11375. 121 EFTA Court of 5 April 2001, Case E-3/00 Efta Surveillance Authority v. Norway, in
EFTA Court Report 2000/2001, p. 73, para 30. For a comment of this case, see Alemanno
2001: 947-950. 122 Commission v. Italy, supra note 119, para 24. 123 Commission v. France, supra note 118, para 61. 124 EC Statute Article 25. 125 ECJ Rules, Article 49 and CFI Rules, Article 70. 126 Case 10/55, Mirossevich v. High Authority [1954-56] ECR 333. 127 Case 12/68, X v. Audit Board [1969] ECR 109. 128 Case 24 and 34/58 Chambre syndicale de la Sidérurugie de l'Est v. High Authority [1960]
ECR 281. 129 Case 48/69 ICI Ltd v. Commission [1972] ECR 619. 130 Case C-169/84, Société CdF Chimie Azote et Fertilisants SA [1990] ECR 3083. 131 Case 204/80 Procureur de la République v. Vedel [1982] ECR 465. 132 See on this point McGarity 2003: 155. 133 For an introduction to peer-review and to the different types of peer involvement, see, e.g.,
Office of Management and Budget, Final Information Quality Bulletin for Peer Review, 15
December, 2004 and Patterson, Mekk, Strawson, Liteplo 2007: 1609-1621. 134 As a result, publications and awards that have not undergone peer review are likely to be
regarded with suspicion by scholars and professionals in many fields. 135 See the Final Information Quality Bulletin for Peer Review by the Office of Management
and Budget (OMB), December 2004, at 2.
82 Alberto Alemanno
136 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection
products on the market (OJ L 230, p. 1-32) was required to be implemented by Member
States from 26 July 1993. The peer-review process is managed by EFSA’s Pesticide Risk
Assessment Peer Review Unit (PRAPeR). 137 Methanex Corp. vs. the United States of America, Final Award of the Tribunal on Jurisdiction
and Merits, in the matter of an international arbitration under chapter 11 of the north
American free trade agreement and the UNCITRAL arbitration rules (Sagarika 2006: 110-
114). 138 The text of the NAFTA Agreement is available at <http://www.nafta-sec-alena.org/>. 139 This substance is a key component in MTBE (methyl tertiary butyl ether), which is used to
increase oxygen content and act as an octane enhancer in unleaded gasoline. 140 In particular, the plaintiff argued that the California ban was tantamount to an expropriation
of the company's investment; a violation of NAFTA's Article 1110, and was enacted in breach
of the national treatment (Article 1102) and minimum international standards of treatment
(Article 1105) provisions. By relying on these arguments, Methanex sought financial
compensation from the United States to the amount of over $900 million U.S. 141 Ibid. 142 The Regulation, supra note 1, Article 6 (3). 143 Most of the EFSA scientific panels are in the process of adopting guidance documents
establishing a method of conducting risk assessment. Thus, for instance, the Scientific Panel on
Genetically Modified Organisms has adopted a Guidance document for the risk assessment of
genetically modified microorganisms and their derived products intended for food and feed use
(The EFSA Journal (2006) 374, 1-115 Summary) and also a Guidance document for the risk
assessment of genetically modified plants and derived food and feed (the EFSA Journal (2004)
99, 1-94).
EU Risk Regulation and Science 83
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The case of the European Commission and the European Food Safety
Autorité’, European Food and Feed Law Review 3: 126-135.
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EU Risk Regulation and Science 85
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86 Alberto Alemanno
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EU Risk Regulation and Science 87
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Chapter 3
Some Suggestions for a Structured Approach to Participation in Food Risk Governance with a Special Emphasis on the Assessment Management Interface
Marion Dreyer and Ortwin Renn DIALOGIK, Stuttgart
Introduction
Food safety policy in Europe is currently a particularly interesting field of
empirical risk research as it is striving to revise the rules and routines of the
governance1 of food risks. At the EU-level as well as in some of the EU
Member States, the overarching objective of this reform process is to restore
what is perceived as a most valuable, however, scarce resource: public trust in
food safety and those responsible for protecting the food supply and
consumer safety. A significant loss of public trust has been diagnosed as the
main consequence of a series of food scares that occurred in the 1990s, with
BSE as the most prominent issue, and of the persistent debate over genetically
modified foods, a technological innovation which despite revised and (in
some aspects) more rigid regulation continues to be a highly controversial
issue.
90 Marion Dreyer and Ortwin Renn
One of the major governance measures designed to remedy the deficit
of public trust is wider public consultation in the process of regulating food safety
risks. At EU-level, declarations of the value of and the need for ‘connecting
with citizens and stakeholders’, ‘open dialogue’, and ‘understanding and
addressing the concerns of stakeholders and consumers’ now represent a
standard part of the official rhetoric. The most significant structural
innovation in this respect is possibly the setting up of stakeholder fora with
the mandate to consult the institution responsible for providing independent,
high quality scientific advice, the authority for risk assessment (the European
Food Safety Authority, EFSA).
At the same time, wider stakeholder involvement in food safety
governance is also a highly disputed issue. Major questions raised by
practitioners and academics alike include: At which stages should the
involvement of so-called ‘interested and affected parties’ reasonably occur?
How is the stakeholder policy of EFSA compatible with the declared aim of
safeguarding the independence of assessment by keeping it separate and free
from the influence of non-scientific considerations? How should the relevant
resources of social groups and possibly also the wider public be fed into the
process without an overkill of participatory procedures that would abuse the
scarce resources (particularly time) of both the responsible institutions and
actors from the ‘outside world’?
This Chapter seeks to address these questions in a discussion of the new
emphasis on ‘improving stakeholder consultation and participation processes’
and related structures and practices in EU food safety governance. It will first
highlight some recent developments in stakeholder involvement in this risk
governance field. This sketch will point out that ‘connecting with citizens
and stakeholders’ continues to be largely restricted to consultation activities.
Drawing on empirical research that was carried out within a larger project
context, the subsequent section will highlight some of the views of key
stakeholders on the recent developments. Subsequently, the authors will
Some Suggestions for a Structured Approach 91
make some suggestions on how to design and put into practice a more
structured approach to stakeholder and public involvement that goes beyond
mere consultation. This approach distinguishes between different purposes of
participation (at the different governance stages) and different levels of
intensity of participation (linked to the likelihood of major societal debate or
conflict surrounding the food safety threat at issue). It comprises permanent
and flexible mechanisms of participation and proposes to institutionalise
stakeholder participation through a committee structure at the interface
between assessment and management, namely at the intermediary stages of
framing and evaluation (at which the inherent inter-linkages between the
scientific and the political aspects of food safety governance are considered to
be particularly strong). The last section will draw some main conclusions.
The New Emphasis on ‘Open Dialogue’ and First
Steps to Open up the ‘Black Box’ of Risk Assessment
The BSE crisis in particular fostered demands for a more effective, fairer, and
more transparent and participatory regulation of food risks. These demands
were motivated by concerns that behind closed doors powerful industry
interests were being advanced at the expense of consumer interests – with
increasing pressures resulting from broader developments such as economic
globalisation and trade liberalisation making this preferential treatment more
likely – and that, partly as a result of this political bias, food substances,
products, or production techniques might be represented and treated as if
they were ‘certainly safe’ while in fact uncertainties were denied or ignored.
Another related underlying concern was that due to food safety regulators
giving precedence to the goals of economic growth and competitiveness the
public’s diverse attitudes and values might not be sufficiently recognised and
respected in the handling of food safety issues. In addition, concerns were
92 Marion Dreyer and Ortwin Renn
expressed relating to the independence of scientific advice, particularly where
considerable political pressure was brought to bear upon scientists.
These demands and worries have been interpreted by academics and
policy makers alike as manifestations of serious legitimacy problems. By the
late 1990s the prevailing diagnosis in European policy circles was that the
level of public trust in both food safety and food safety institutions had
seriously declined and that institutional frameworks needed to be improved in
order to restore public trust and social legitimacy.
At the EU-level (as well as in a number of EU Member States) food
safety institutions were subjected to review and reform. The core of the
reforms at the EU-level is the allocation of responsibilities for risk assessment
and risk management to separate institutions destined foremost to assure the
independence of scientific analysis and advice. This division of responsibilities is
codified in the new European Parliament and Council Regulation 178/2002,
widely known and referred to as the ‘General Food Law’.2 The EU (and
among the Member States also very much the UK) has also resorted to
reforms designed to uphold the procedural legitimacy3 of food safety governance
by incorporating democratic norms in the process of dealing with food safety
issues.4 Advancement of the democratic quality of the governance process forms
another major response to the situation of ‘contested governance’ (Ansell and
Vogel 2006).5 It is formulated on the website of the European Commission’s
Directorate General for Health and Consumer Protection (DG SANCO) as
follows: ‘Transparency of legislation and effective public consultation are
essential elements of building this greater [consumer] confidence’.6 There are
three major modes by which this purpose was expected to be served in food
safety regulation (Dreyer, Renn, Borkhart and Ortleb 2006):
- by making the risk analysis process, including risk assessment, more
transparent through wider public documentation (including the
publication of all the opinions adopted by EFSA’s Scientific Committee
Some Suggestions for a Structured Approach 93
and Panels on the Authority’s website; in future all mandates will also be
posted on EFSA’s website7);
- by offering more readily comprehensible and process-oriented information
on the risk to the public at large, specifically addressing major consumer
concerns;
- and by providing more and improved opportunities for the consultation of
economic and civil society actors in relation to both assessment activities
(with EFSA’s Stakeholder Consultative Platform taking a prominent
position) and management activities (with the Advisory Group on the
Food Chain and Animal Health taking the lead8).
Consultation on the concerns, views, and interests of commercial and civil
society actors operating in the food chain is the typical form which the
involvement of social groups in food safety regulation takes. Stakeholder and
public consultation constitutes one of the major pillars on which the General
Food Law rests.9 The Law stipulates that, with the exception of urgent
matters, there shall be ‘open and transparent public consultation, directly or
through representative bodies, during the preparation, evaluation and revision
of food law’.10 Furthermore, it specifies that EFSA shall develop ‘effective
contacts with consumer representatives, producer representatives, processors,
and any other interested parties’ in the course of risk assessment.11 The Law is
also specific about the participation component in risk management, which is
defined as being about ‘weighing policy alternatives in consultation with
interested parties’.12 This is in line with the concept of risk communication
advocated by the Commission’s White Paper on Food Safety, which defines
it as an interactive and involving dialogue with and feedback from
stakeholders.13 Public consultation directly relates to participation as one of the
five normative principles of ‘good governance’ which the European
Commission has identified in its White Paper on European Governance. It
requires governance institutions to ensure wide participation from the
94 Marion Dreyer and Ortwin Renn
conception of policy options right through to the implementation of
decisions.14
The practice of consultation in food safety governance is certainly not
new, at least in relation to decision-making in the area of risk management.
At the EU-level, representatives of the various interest groups were consulted
through the Advisory Committee on Foodstuffs. This committee, which in
the past was not regularly convened by the Commission (Joerges and Neyer
1997; Vos 2000: 230), was restructured and revived in 2004 as the Advisory
Group on the Food Chain and Animal Health (Vos and Wendler 2006). In
addition to this formalised setting of consultation, stakeholders have always
been consulted on an informal basis. The frequency, intensity and
selectiveness with which this occurred have been heavily dependent on the
discretion of individual risk managers. Empirical research suggests that these
informal contacts behind closed doors continue to be of high importance.
The most notable change to the traditional policy of involvement so far
is possibly that the former ‘black box’ of risk assessment has been opened up
(in part) to stakeholder consultation. Meanwhile, the consultation activities of
EFSA, which has the role of the risk assessor,15 comprise such various
practices as public consultations, annual colloques,16 technical
meetings/hearings, conferences, scientific colloquia, and the Stakeholder
Consultative Platform. With the setting up of the Platform, EFSA
institutionalised stakeholder consultation through a permanent body. The
Platform was established in 2005 as a forum of regular dialogue and
exchanges; it is composed of EU-wide stakeholder organisations operating in
the food chain and within EFSA’s remit and has the task of assisting the
Authority in developing its overall relations and policy with regard to
stakeholders.17
The subject matters of the different consultation activities of EFSA
include the Authority’s broader policy such as its strategic objectives, its work
programme and its overall approach to stakeholder involvement (dealt with
Some Suggestions for a Structured Approach 95
foremost by the Platform), as well as such practical matters as guidance
documents for risk assessors and authorization applicants.18 Increasingly, EFSA
also subjects matters which are closer to the core of the risk assessment
activities to stakeholder or public scrutiny. These consultation activities
include stakeholder or public consultations on draft opinions, on general or
issue-specific approaches and methodologies for risk assessment,19 and also,
envisioned for the near future, consultations on draft opinions dealing with
complex food safety issues.20 Furthermore, EFSA uses web-based
consultations for public requests for input of relevant data and information.21
The above sketch of some of the recent developments in the policies of
involvement in food safety governance at EU-level indicates that there is
continuity in organising public involvement in most part as the ‘elicitation of
responses to pre-formed proposals’22 (i.e. to consultation activities) that is in
contrast to ‘symmetrical two-way deliberation’ with the potential to
empower inputs from different social actors. At EFSA, empowerment to
influence decision-making is restricted to the management level where the
Authority provides for a formal representation of different interests (four of
the Management Board members, out of fourteen, are required to have a
background in organisations representing consumers and other interests in the
food chain).
There is change in that the risk assessment business, now segregated
from risk management in a separate institution, has been opened up to
stakeholder consultation in selected matters. There is also change from the
status quo ante in that consultation in both risk assessment and – even though
EFSA does not have authority over this – risk management occurs on a more
regular basis (mainly through the Advisory Group on the Food Chain and
Animal Health and the Stakeholder Consultative Platform), and also
increasingly in a more open manner (which contrasts with and assumedly
96 Marion Dreyer and Ortwin Renn
complements rather than substituting, informal and confidential ‘behind
closed doors’ consultations).
A Sketch of Stakeholder Views of the Reform
Policies
The present section highlights some of the responses of stakeholders towards
the recent reform efforts in EU-level stakeholder policies. They were elicited
during the past three years through interviews and workshops with key
stakeholders in the field of food safety governance.23
One of the findings of this empirical investigation is that the
consultation of stakeholders during the governance stage of risk management
is widely acknowledged, while the new practice of opening up the stage of
risk assessment to some degree to stakeholder and public consultation is not
accepted unquestioningly. The inclusion of stakeholders in the course of risk
assessment is still disputed and has an exploratory character. By no means
were all interviewees convinced about the necessity of having ‘affected and
interested parties’ involved in an activity that should be governed by data
gathering and analysis, and safeguarded against inappropriate non-scientific
influences; but nor did they have clear ideas about appropriate ways to do
justice to this legal imperative (Vos and Wendler 2006: 124). According to
various Commission officials who were interviewed, a viable option to
greater public involvement as regards risk assessment would be to consult
stakeholders more regularly at the moment of drafting the terms of reference
and after the presentation of the assessment report (Vos and Wendler 2006).
Not surprisingly, the greater importance attached to the representation
of consumer interests – through the Commission’s Advisory Group on the
Food Chain and Animal Health, EFSA’s Stakeholder Consultative Platform
and EFSA’s Management Board – is generally welcomed by representatives of
Some Suggestions for a Structured Approach 97
non-governmental organisations (NGOs). Various participants at a workshop
with NGO representatives (conducted within our empirical research, cp. ft.
24) pointed, however, to the continuing challenges faced by NGOs as a result
of unequal power relations and access to resources between different actors in
food safety governance, in which informal contacts behind closed doors
would continue to be of high importance. In particular, the possibility that
governance questions would be framed by the powerful corporate sector
means in their view that it is important to have formal NGO involvement
already at the earliest stage of the governance process when the problem is
defined and the terms of reference are set, and certainly at those stages at
which necessary action and means of action are deliberated and concluded
(Ely and Stirling 2006; Vos and Wendler 2006: 124).
Public consultation is at present for the most part organised as
stakeholder consultation. This gives in particular the bigger and more
prominent organisations (the ‘Brussels stakeholder establishment’) a voice
(prominently within the framework of the Advisory Group on the Food
Chain and Animal Health and the Stakeholder Consultative Platform).24
Several representatives of smaller NGOs challenged this practice emphasising
that NGO inputs to the governance process should be as diverse as possible,
rather than focussing on a small number of the large NGOs. They stressed the
need to recognise and respect the greater diversity of voices, perspectives, and
values that are usually involved in food safety issues. At the same time, they
underlined the generally limited resources of NGOs and the scarce resources
of the smaller NGOs or of citizens to invest on a regular basis in the
regulation of food safety (Ely and Stirling 2006).
98 Marion Dreyer and Ortwin Renn
Some Suggestions for a Structured Approach to
Participation Including ‘Interface Deliberation’
This section25 aims to address the issues set out above by providing some
suggestions for how to achieve a more structured engagement of EFSA and
the Commission with a diversity of social groups in a way which includes the
earliest stage of the governance process, maximises valuable input
(knowledge, interest, value preferences) into the governance process while
avoiding the process and participants’ resources being overburdened by
excessive participation on every food safety issue, and which goes beyond
mere consultation.
Participation at Four Stages of Governance Tailored to the Purposes
Served at the Different Stages
A recent publication on the role of expert advice in the governance of
science and technology states rightly that ‘public engagement is not a stage of
governance that can be completed, tidied up and filed away’ (Stilgoe, Irwin
and Jones: 2006: 53; see also Jasanoff 1993: 123-129). Instead, public
engagement should be understood as an inherent element of the whole
process of governance and thus raises the more exigent question of how to
incorporate the perspectives and specialized knowledge of interested and
affected parties early and meaningfully into the process.
One way in which to address this question in a first step is to
distinguish between different purposes of participation that are served at the
different stages of the governance process. We propose to distinguish four
essential stages of governance: assessment and management as the two well-
established components of risk analysis, and two additional stages: firstly,
framing which encompasses the definition of the respective problem and the
setting of the terms of reference for assessment, and, secondly, evaluation
which relates to the process of assimilating and deliberating upon the outputs
Some Suggestions for a Structured Approach 99
of the assessment phase and considering the tolerability or acceptability of a
given food safety threat more explicitly.26
Advocating the addition of these two stages is not to claim to propose
something entirely new: in the current food safety governance system framing
and evaluation activities are inevitably also carried out, so to speak. However,
these activities are carried out in a manner that is barely transparent. The step
of evaluation is, moreover, exercised in a manner that is largely implicit and
ad-hoc, and responsibilities are not clear: is evaluation a task carried out/to be
carried out by assessors or by managers or by both?
The key feature of framing and evaluation is that they constitute
interfaces between the assessment stage, which is focused on knowledge
generation and collection, and the management stage, which is focused on
value-laden decision-making in a jigsaw puzzle of facts, uncertainties,
stakeholder interests, and public concerns. They are interface tasks in so far as
they draw on both scientific knowledge and political and socio-economic
considerations: the tasks of framing need to be governed by societal values
(stating the goals, objectives and contextual conditions) and inspired by what
we already know about the threat (suspected impacts, exposure, persistence,
and others). Similarly, during the phase of evaluation, the tolerability/
acceptability judgement requires a good understanding of the web of
evidence, residual uncertainties, and ignorance (i.e. of the scientific
characterization of the threat), as well as a judgmental competence for making
the necessary trade-offs between risk, benefits and other relevant impact
categories. In that sense, framing and evaluation are, so-to-speak, ‘hybrid’
activities. The proposed formalisation of these two activities as governance
stages in their own right is a way to account for the inherent inter-linkages
between the scientific and political aspects of food safety governance (which
are in the current governance system often obscure and lie outwith the view
of democratic accountability), and at the same time to not compromise the
100 Marion Dreyer and Ortwin Renn
functional differentiation between assessment and management activities (as
provided for in the General Food Law).
The proposed four-stage-structure of food safety governance avoids, on
the one hand, the naïve decisionistic separation in values here and facts there,
and, at the same time, escapes post-modern relativism in its extreme version
by honouring the analytical distinctions between the factual and the desirable
world even if they clearly interact. That way, the four-stage structure has
potential to create more accountability by enhancing clarity over the nature of
the reasoning underlying governance outcomes, in particular over the way in
which knowledge and value inputs relate to management decisions.
Moreover, the formalisation of the stages of framing and evaluation improves
political and public accountability by clarification of the responsibilities for
essential governance activities.
In order to define the different purposes of participation served at the
four governance stages we propose to distinguish between four discourse
categories: a design discourse (generic to the framing stage); an epistemic
discourse (generic to the assessment stage); a reflective discourse (generic to
the evaluation stage); and a practical discourse (generic to the management
stage).27 The following paragraphs provide a brief description of the four
discourses and the role participation takes in them.
Participation at the stage of framing means involvement at the earliest
stage of governance. Participation here concerns contributing to a design
discourse. This discourse is aimed at setting the terms of reference, including
the scope, focus and design of assessment, and at specifying the way (breadth,
concrete procedures) in which stakeholders and/or the wider public are
included in the assessment process.
The epistemic discourse at the stage of assessment comprises
communication processes, in which experts of knowledge (not necessarily
scientists) grapple with the clarification of a factual issue. The goal of such a
discourse is the representation and explanation of a phenomenon as close to
Some Suggestions for a Structured Approach 101
reality as possible. By knowledge, we refer to systematic knowledge collected
by established means of natural and social sciences and experiential knowledge
collected by interactive techniques such as hearings or focus groups. Both
types of knowledge are important for describing what we generally know
about the food safety threat (or about a set of functional equivalents to a
threat source) and what we have learned in dealing with the threat or a
similar threat source in the past. Subject to the provisions of framing, civil
society actors and also the wider public may contribute to the broadening and
refining of the infrastructure of knowledge and information upon which
evaluation and management decisions draw. It is important to note, that it is
not the task of stakeholders and representatives of the wider public in the
epistemic discourse to deal with normative questions pertaining to the
acceptability or tolerability of either the threat itself, different strategic options
(a set of products/processes/practices which are possible alternatives to the
option in question), or management measures for dealing with the threat.
These normative issues are part of the evaluation and management phases.
They are based on value judgements about what is ‘desirable’ rather than
what is ‘true’.
The reflective discourse encompasses communication processes dealing
with the interpretation of factual issues, the clarification of preferences and
values and a normative judgement of tolerability or acceptability. It is mainly
suitable for balancing pros and cons, weighing the arguments and reaching a
balanced decision on the basis of the epistemological discourse and social
values and preferences. The main purpose of participation here is to ensure
that all values and preferences are included in the weighing procedure, and
that the final judgement reflects the societal balance between innovativeness
and caution.
The practical discourse involves communication processes aimed at the
identification, assessment, and selection of different management measures for
102 Marion Dreyer and Ortwin Renn
reducing and managing ‘intolerable threats’ or ‘tolerable but not acceptable’
threats. This discourse looks at the variety of possible interventions, addresses
the pros and cons for each measure or package of measures and suggests a set
of measures that appear to be effective, efficient and fair. The main purpose
of participation is here to assure that relevant knowledge and different
preferences are considered in the conclusions on the selection of one or more
management measures.
Each of the four discourses produces different types of outcomes that
are fed into the next governance stage and enlighten the politically
accountable decision makers. It is stressed that, while all participants should
have equal rights in the deliberation processes themselves, the responsibility
for the final decision lies with the risk managers.
Institutionalisation of Participation in a Committee Structure at the
Interface Stages of Framing and Evaluation
It was underlined above that the inter-linkages between the scientific and
political aspects of food safety governance are particularly strong where food
safety problems are framed and evaluated. This ‘hybrid’ character of framing
and evaluation is likely to explain at least in part the need for the improved
interaction between assessors and managers in the performance of these
activities called for by several EU-level and Member State assessors and
managers, whose views were elicited in the study of the governance systems
at the EU-level and in France and Germany, where assessment and
management responsibilities are allocated to different institutions (Dreyer,
Renn, Borkhart and Ortleb 2006: 24-30).
As was already mentioned in Section 2, this institutional divide is the
primary feature of the current institutional framework of EU food safety
regulation (with the newly established EFSA being located in Parma, and the
European Commission being located in Brussels). In terms of loss of trust, the
Some Suggestions for a Structured Approach 103
remedy resorted to in this new institutional design is the trust-generating
power of what is represented as ‘independent risk assessment’.28 Safeguarding
scientific analysis against distortion by inappropriate policy influences and
considerations is intended to re-establish and assure the credibility of risk
assessment activities and results on which risk management decisions are to be
based.29 However, it is precisely the segregation of risk assessment
responsibilities that highlights that scientific activities cannot be performed in
complete isolation or in a political vacuum.30 In the first couple of years
following the establishment of EFSA, much of the official rhetoric tended to
evoke the idea of assessors and managers doing their jobs in strict separation
and sequence. Various interviewees and also several participants at the
stakeholder workshops stressed, however, that this concept has never
represented the practical reality in which interaction occurs and is deemed
necessary. There exist obvious tensions between public legitimisation needs
(insulating science from policy) and practical action requirements. The
experience with the new institutional divide has increasingly brought to light
that problems might arise if the need for interaction is not adequately
accounted for in the risk governance process, and many assessors and
managers see here room for improvement.31
We propose to account for this need for improvement by assigning
framing and evaluation tasks to a committee that brings together managers
and assessors as well as key stakeholders and act in an advisory function. This
‘interface committee’ would advise on the terms of reference at the stage of
framing and reconvene at the stage of evaluation to use the new knowledge
from the assessment to draw normative conclusions about the food safety
threat under consideration, which would then advise the risk managers in the
decision-making. Through membership in this committee, key stakeholders
in food safety governance (including industry and consumer organisations)
would be involved at an early stage in the governance process. Moreover, the
104 Marion Dreyer and Ortwin Renn
setting up of such a committee would facilitate the co-ordination between
political decision-makers, knowledge experts, and social groups at those stages
at which accounting for facts and values is of primary importance. The role of
the stakeholders sitting on the committee would go beyond mere
consultation. Instead, they would participate in deliberative exercises as
members with equal rights.32
The selection of a few ‘key stakeholders’ to sit on the interface
committee would inevitably provoke questions of representativeness, power,
and fairness. Therefore, the establishment of a second interface link that is
more inclusive in terms of the voices that it invites to engage in deliberation
over framing and evaluation issues might be considered. This broader link
could take the form of a web-based function that offers platforms for an
exchange of views and consultation that relate to the (draft) outcomes of the
four governance stages that are documented and opened up for public
scrutiny. The proposal for such an ‘internet forum’ has been spelled out
elsewhere.33 The main idea is to invite and expect participants of the internet
forum to not merely state their opinions but to also exchange views, i.e. to
discuss each others’ standpoints and arguments. Hence, this participatory
instrument also extends beyond (however, is intended to include)
consultation: it should provide the European Commission and the proposed
interface committee not only with individual feedback but with feedback
based (at least in part) on discussion, reflection, and persuasion, i.e. with
opinions mutually informed by a diversity of views. Certainly, the breadth
and intensity with which individual cases would be discussed can be expected
to vary greatly depending on the potential for conflict that might be implied
in the cases. In that sense, the internet forum could act both as an entry point
at major governance stages of a diversity of viewpoints into the governance
process, and as a signal for highly controversial issues with a great potential for
social mobilisation.
Some Suggestions for a Structured Approach 105
A Guiding Tool for Deciding on Extended Participation
Particular cases might require a more extensive participatory programme
(extending beyond the inclusion of stakeholders through the
framing/evaluation committee and web-based consultations and
deliberations). We would propose to proceduralise decision-making over any
possible extension of the scope of participation and concerning the selection
of appropriate processes. It would be part of the mandate of the interface
committee to give advice on this matter in consideration of the specific case
and the given context and the overall socio-political climate.34
Aspects that could inform this decision-making process may come from
the internet forum as well as the stakeholders who sit on the interface
committee, who can act as ‘sensitivity sensors’ for highly controversial issues
that call for broader participation. In addition, those consultative stakeholder
bodies that have been established in the recent years, namely EFSA’s
Stakeholder Consultative Platform and stakeholder colloquia and the
European Commission’s Advisory Group on the Food Chain and Animal
Health, might be of some assistance in this respect.
While these sources of information already have some potential for
facilitating decision-making around the need for broader participation, we
would recommend, in addition, to apply the preliminary assumption that under
more intractable conditions of high levels of scientific uncertainty and/or socio-
political ambiguity a higher degree of participation is required. Uncertainty, as
defined here, includes those states of knowledge where either the possible
outcomes are clear, but it is difficult to quantify probabilities, or where
neither probabilities nor outcomes may be fully or confidently characterised
(more specifically the latter state may be referred to as a state of ‘ignorance’).
Under the circumstance of ambiguity, the problem lies not with probabilities,
but in agreeing the appropriate values, priorities, assumptions, or boundaries
that apply in defining the possible outcomes. Socio-political ambiguity
106 Marion Dreyer and Ortwin Renn
focuses on the degree to which a given food safety threat may be subject to
strongly divergent cultural attitudes, political perspectives or economic
interests.35 The presumption is that under the circumstances of high levels of
scientific uncertainty and/or socio-political ambiguity the likelihood of major
societal debate or conflict surrounding the threat under review is also higher
and hence extended participation advisable.
What could such an extended participation look like? Under conditions
of scientific uncertainty, stakeholders should be asked to administer their specific
knowledge in the assessment process regarding the likely consequences of the
product/process/practice in question that carries a certain threat. The more
uncertain the given threat is, the more a communicative exchange among
experts of a great diversity of disciplines and also practical backgrounds is required to
reach a coherent description and explanation of the phenomenon.
Frequently, these discourses are capable only of showing the range of the still
methodically justifiable knowledge, i.e. defining the boundaries between the
absurd and the possible, between the possible and the likely, and the between
the likely and the certain. Methods for this type of involvement include the
Delphi and Group Delphi method, scientific consensus conferences and
meta-workshops (Turoff 1970: 84-98; Webler, Levine, Rakel and Renn
1991: 253-263). Under conditions of high scientific uncertainty stakeholders
should also be invited to engage in a comparative review and administer their
specific knowledge in relation to a range of alternative options (i.e. functional
equivalents) to the product/process/practice in consideration. The realm of
knowledge that is needed to characterise uncertain threats expands the scope
of traditional risk analysis and includes expertise about social benefits
associated with the threat or its alternatives, about possible substitution
pathways, potential for using ‘forgiving’ technologies, etc. Methods such as
stakeholder surveys, qualitative interviews, focus groups and public hearings
are most appropriate for this task. Stakeholder participation is also advisable at
the stage of evaluation, to reflect collectively on the balancing of the
Some Suggestions for a Structured Approach 107
possibilities for over- and under-protection, and at the stage of management,
to balance the pros and cons associated with each of the potential
intervention measures. Methods for these purposes include round tables,
negotiated rule-making exercises or mediation (Stolwijk and Canny 1991:
33-48; Bacow and Wheeler 1984; Burns and Ueberhorst 1988; Review in
Fiorino 1990: 226-243).
Food safety threats characterised by a high level of socio-political
ambiguity require the most inclusive strategy for participation since not only
groups directly affected but also those indirectly affected have something to
contribute to the debate. Dealing with ambiguity in food safety debates
necessitates, at the stage of assessment, eliciting as widely as possible the
concerns, perspectives, and preferred options that the relevant social groups, on the
basis of their specific knowledge and information, have regarding the case
under review. If there are indicators (for instance through the deliberations
on the internet forum) that a major debate involving the wider public is
desired, it might be necessary also to conduct face-to-face inquiries among
different groups and representatives of the wider public. Methods for this type
of involvement include focus groups, stakeholder interviews, hearings and
other interactive elicitation methods, such as value tree analysis, option
mapping, and others. At the evaluation stage, a platform – complementary to
the interface committee – is required where citizens are also involved, and
competing arguments, beliefs and values are openly discussed. The
opportunity for resolving these conflicting expectations lies in the process of
identifying common values, defining different angles or perspectives that
allow people to apply their own vision of a ’good life’ to judging the
acceptability or tolerability of threats without compromising the vision of
others. Available sets of deliberative processes in which a randomised or
deliberately stratified group of citizens work to scope and explore the issues
and options in contention include citizen panels, citizen juries, consensus
108 Marion Dreyer and Ortwin Renn
conferences, ombudspersons, and citizen advisory committees, and others (see
Kasemir, Clark, Gardner, Jaeger, Jaeger and Wokaun 2003; Joss 1999: 290-
373; Renn, Webler, Rakel, Dienel and Johnson 1993: 189-214; Kathlene
and Martin 1991: 46-63; Crosby, Kelly and Schaefer 1986: 170-178; for
reviews see Hagendijk and Irwin 2006: 167-184; Rowe and Frewer 2000: 3-
29; Lynn 1990: 95-101). In addition, classic stakeholder engagement
processes such as hearings and web-based consultations might accompany the
public participation program. Furthermore, if the management measures are
also highly contested, it seems advisable to organise a broad societal discourse
about the appropriateness of these measures and the best way of finding a
consensus or an agreement on the measures to be taken. The methods for
addressing ambiguity in the evaluation process are also appropriate for
handling ambiguity in the selection of management measures.
Concluding Remarks
Scholars in the field of science and technology policy have noted that public
participation in techno-scientific issues ‘has recently gained mainstream
support in Europe’ (Levidow 2006) in response to greater conflict around
innovation and the regulation of disputed technologies, and as a remedy for
‘deficits’ of public trust. The BSE crisis and other food-related scares and the
controversy over genetically modified food have greatly contributed to this
general development and to the current emphasis on public participation in
food safety governance. What has been stated for the general field of scientific
governance by a science and technology studies’ scholar seems to be good
advice for the field of food safety governance as well: to take an ‘analytically
sceptical (but not dismissive) perspective’ (Irwin 2006: 300) on the ‘new’
governance mode because ‘enhanced engagement alone cannot be presented
as an antidote for public scepticism over technical change’ (Irwin 2006: 315).
While there is much to be said in favour of public scepticism as one
Some Suggestions for a Structured Approach 109
instrument of democratic control (so why eliminate it), it is also the position
of the authors of this paper that inclusive governance is neither a panacea for
better risk governance nor a guarantee for more democratic processes. Yet, it
is also the firm conviction of the authors that given the right conditions,
structures and processes, inclusive governance has the potential to improve
decision-making and to add substantially to the rationality and democratic
quality of risk governance.
Participation in food safety governance is currently a dynamic policy
field, where the use of new participatory mechanisms – largely restricted to
new consultation mechanisms – is still at an exploratory and experimental
stage. We have presented in this Chapter some suggestions for how to
respond to some of the key issues that are currently discussed in regard to
these dynamics (for an overview of our suggestions see the table below).
The distinction between stage-specific purposes of participation is
proposed as a conceptual basis on which to organise valuable input
(knowledge, interests, value preferences) into the governance process without
compromising the functional separation between assessment and
management, while at the same time accounting for the interface stages at
which activities aimed at ‘understanding’ risks and activities aimed at ‘acting’
on risks are strongly interlinked.
The representation of stakeholders on the interface committee at the
stages of framing and evaluation allows for an early involvement of
stakeholders in the governance process and for real engagement (in the sense
of symmetrical two-way deliberation) at the two stages at which facts and
values most strongly interact. The internet forum could add to the
inclusiveness of the governance process by opening up all governance stages
to public scrutiny and by inviting a much greater diversity of social groups to
engage with the governance process. These two institutional provisions have
the potential to improve the coordination between political decision-makers,
110 Marion Dreyer and Ortwin Renn
expert advisors, and corporate and civil society actors in the governance
process, and to create a greater accountability for contesting political-
economic interests and socio-cultural values that can underpin the outcomes
of food safety governance.
We recommend additional participatory processes for those food safety
threats that are associated with high levels of scientific uncertainty and/or
socio-political ambiguity. No major effort is required to include stakeholders
or citizens for ‘routine’ food safety risks. This provision is proposed to
account for the particular challenges implied in the handling of uncertain
and/or ambiguous food safety threats and as a way to ensure that participatory
policies do not end up in ‘stakeholder fatigue’ (this term seems to develop
into a buzzword in academic and stakeholder circles) or, in more general
terms, into ‘dialogue fatigue’ (Irwin 2006: 316). This could result from
participatory policies that rely upon quantity rather than the quality of
participation processes. It is important to note that both the food safety
institutions and those invited to engage with the governance process need to
ensure that their resources are used efficiently. It is, however, the firm
conviction of the authors of this Chapter, that for some of the most
challenging food safety threats a broad participatory programme can lead to
governance outcomes that are better informed, better balanced, and socially
more robust.
Some Suggestions for a Structured Approach 111
A structured approach to participation36
Governance
stage
Style of
discourse
Purpose
As a
contribution
to:
Institutionalised
Participation
Additional
participatory
processes
Framing Design Drawing up
the terms of
reference
Assessment Epistemic Gathering of
knowledge
and
information
Evaluation Reflective Value-based
judgements
on tolerability
or
acceptability
Management Practical Selection of
appropriate
measures
Via an Internet
Forum throughout
the governance cycle
At the stages of
framing and
evaluation: via
stakeholder
representation on the
Interface Committee
Procedurally,
context dependent,
and specified at the
stages of framing
and evaluation
Prima facie default:
high levels of
scientific
uncertainty and/or
socio-political
ambiguity require
extended
participation
112 Marion Dreyer and Ortwin Renn
Notes
1 The food safety governance process is understood to include, but also to extend beyond, the
three conventionally recognised elements of risk analysis (risk assessment, risk management and
risk communication). ‘Governance thus includes matters of institutional design, technical
methodology, administrative consultation, legislative procedure and political accountability on
the part of public bodies and social or corporate responsibility on the part of private
enterprises. But it also includes more general provision on the part of government, commercial
and civil society actors for building and using scientific knowledge, for fostering innovation
and technical competences, for developing and refining competitive strategies and for
promoting social and organisational learning’ (Ely et al. 2007: 9). 2 Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January
2002 laying down the general principles and requirements of food law, establishing the
European Food Safety Authority and laying down procedures in matters of food safety, OJ
2002 L31/1 (hereafter: ‘General Food Law’). 3 The exposition adopts here the argumentation by Grace Skogstad, who suggests in her
analysis of GMO regulation in the EU that, ‘all strategies to render policies acceptable by
virtue of democratising the procedures by which they are arrived at can be viewed as input-
oriented legitimation’ (Skogstad 2003: 324). While the ‘test of appropriateness’ under output
(or results-based) legitimation standards was the perceived merit of policy outcomes, the merit
of this test under input (or procedure-oriented) legitimation standards was the conformity of
decision-making procedures with democratic norms of public participation and control (324-
325). 4 The same holds true for the UK and Germany, and to a lesser extent for France, which have
also declared the (re-)establishment of consumer confidence as one objective of their revised
food safety policy (Dreyer, Renn, Borkhart and Ortleb 2006: 57). 5 The editors of this book refer to the situation of ‘both sudden and pervasive loss of trust and
legitimacy and an uphill battle to restore it’ (Ansell and Vogel 2006: 20) as ‘contested
governance’ and argue that European food safety regulation over the past decade exemplified
such a case. 6 DG SANCO website: <http://ec.europa.eu/food/food/foodlaw/principles/index_en.htm>
(accessed on 15 March 2007). For the overarching field of policy-making on health and
consumer protection, DG SANCO has recently launched the ‘Health Democracy’ initiative
(Health Democracy: Building Stakeholder Involvement in DG SANCO). This initiative has as
its purpose the identification of the areas of possible improvements in the existing consultation
Some Suggestions for a Structured Approach 113
system as well as the tools that are necessary in order to enable DG SANCO to better consult
its stakeholders. DG SANCO was assisted in this effort by a Peer Review Group composed of
key stakeholders, Member States and consultation experts. 7 Currently, only a few mandates are available, including mandates on nutrition, cloning, and
risk-benefit analysis. 8 Moreover, the European Commission has established a system of online consultation, ‘Your
Voice in Europe’, under which specific consultations in the area of food safety management
and policy have been realised. 9 Two further major cornerstones are the application of principles of independence, objectivity
and transparency in risk analysis, and the application of the precautionary principle in the face
of scientific uncertainty. 10 General Food Law, supra note 2, Art. 9. 11 General Food Law, supra note 2, Art. 42. 12 General Food Law, supra note 2, Art. 3(12). 13 CEC, Commission of the European Communities, White Paper on Food Safety, COM(1999)
719 final, 12 January 2000, Brussels. 14 CEC, Commission of the European Communities, European Governance: A White Paper,
COM(2001) 428 final, 25 July 2001, Brussels. 15 Put more precisely, EFSA has the dual role of both risk assessor and risk communicator, and
thus the mandate to provide the European Commission, the Member States and the European
Parliament with independent, high quality scientific advice and to communicate about its
findings. 16 The Colloque is targeted at industry, farmer groups, consumer groups, and other non-
government organisations and intended to be ‘an interactive and participative event that
facilitates work, debates and breakout sessions’ (EFSA website). 17 The inaugural meeting took place in Parma, 6-7 October 2005. The Platform holds
meetings twice a year in Parma (EFSA website). Currently it consults the Authority on an
external review of EFSA’s stakeholder policy. 18 EFSA is currently (May/June 2007) undertaking a public consultation via the Authority’s
website on a Guidance Document for Application to Authorizations of Health Claims; speech
by C. Geslain-Lanéelle, the Executive Director of EFSA, at the meeting of EFSA’s Stakeholder
Consultative Platform on 26-27 April 2007, Parma, Italy. 19 To give some examples: the scientific panel of EFSA that deals with genetically modified
organisms undertook a stakeholder consultation in relation to a Draft Guidance Document for
the Risk Assessment of Genetically Modified Plants and Derived Food and Feed, and only
114 Marion Dreyer and Ortwin Renn
recently a public consultation on a Draft Report on the Safety and Nutritional Assessment of
GM Plant Derived Foods/Feeds: The Role of Animal Feeding Trials; EFSA’s Scientific
Committee carried out a public consultation on a Draft Opinion on a Harmonised Approach
for Risk Assessment of Compounds that are Both Genotoxic and Carcinogenic; also very
recently, a working group at the Stakeholder Consultative Platform has been established to
consult EFSA’s Scientific Committee on the issue of ‘Transparency in Risk Assessment’. 20 It is planned that the Draft Opinion on Animal Cloning will be open for comment and
public review, likely to be followed by a public consultation meeting; speech by H. Koëter,
Deputy Executive Director of EFSA, at the meeting of EFSA’s Stakeholder Consultative
Platform on 26-27 April 2007, Parma, Italy. Other envisioned areas of further stakeholder
involvement in addition to cloning are nutrition and nanotechnology; speech by C. Geslain-
Lanéelle at the same meeting. 21 For instance, the work on the European Commission request for an opinion on animal
cloning will start with a public request for input of relevant data/information through a web
consultation; speech by H. Koëter at the meeting of EFSA’s Stakeholder Consultative Platform
on 26-27 April 2007, Parma, Italy. 22 A. Stirling uses these terms to describe the ‘bottom line recommendation’ of a European
Commission Workshop dealing with the topic of ‘From Science and Society to Science in
Society: Towards a Framework for ‘Co-operative Research’ (24-25 November 2005): ‘…
European activities in these areas [the governance of research and the scientific advice process]
should be informed by, and should themselves incorporate, more effective forms of
symmetrical two-way deliberation, empowering inputs from a wide diversity of social actors’
(Stirling 2006: 4). 23 This empirical work was conducted within the fifth subproject (so-called work package 5) of
the EU-funded Integrated Project ‘SAFE FOODS’. The interviews were conducted for an
account of current institutional arrangements and recent reforms in food safety governance at
the EU-level (see Vos and Wendler 2006: 65-138). For the purpose of this study 13 persons
were interviewed (between April and July 2005), of whom 9 were from DG SANCO of the
Commission, 1 from EFSA, and 3 from stakeholder associations. The workshops were held to
inform on the development of a proposal for an innovative food safety governance framework,
which includes the suggestion for a structured approach to participation (see Dreyer, Renn,
Ely, Stirling, Vos, Wendler 2007). The workshops involved, successively, industry
representatives, NGO representatives, risk managers, and risk assessors. The fifth and final
workshop brought together all of the four actor groups. The first four workshops were
conducted through the Autumn of 2006, with the final ‘mixed’ workshop being held in May
Some Suggestions for a Structured Approach 115
2007; the participants were selected from across Europe including the EU-level. In each case, a
summary report of the workshop was produced and circulated to the participants to ensure
accuracy and provide the opportunity for further feedback. 24 To be sure, the Commission also organises regular public consultations on various topics
where everyone is invited to comment. 25 The section draws on parts of the chapter ‘A Structured Approach to Participation’ (see
Dreyer, Renn, Ely, Stirling, Vos and Wendler 2007: 90-97). 26 The four-stage structure draws on the Integrative Approach to Risk Governance advocated
by the International Risk Governance Council (see Renn 2005). 27 The labels for these different discourse types were first introduced by Renn 1999: 115-130. 28 While official rhetoric often evokes the idea of ‘science only’ in this respect, scholars in the
field of science and technology policy have persuasively argued that this model is misleading
even in theory: the specific approach of a particular risk assessment, including e.g. the selection
of impacts to assess, the disciplinary perspectives to shed light on these impacts, and the choice
of more or less conservative safety factors, inevitably involves non-scientific considerations and
value judgements, be they explicit or implicit (Millstone 2000: 818; Millstone and van
Zwanenberg 2002: 603; Jensen and Sandøe 2002); see also the National Research Council’s
‘Red Book’ which argues that the description of risk assessment as a strictly scientific
undertaking was a misconstruction (National Research Council 1983: 150). 29 At Member State level, this approach is especially pronounced in France and Germany,
where responsibility for the functions of risk assessment and risk management have also been
allocated to different institutions. 30 The NRC’s ‘Red Book’ also highlighted a central and well-founded criticism of ‘full
organizational separation’, stating that ‘simply separating risk assessment from the regulatory
agencies would not separate science from policy’, supra note 28, p. 139. 31 Cp. EFSA document 2006; DG SANCO 2005: 2. The increasing emphasis on the need for
interaction corresponds with the Codex Working Principles for Risk Analysis, which
emphasize that risk analysis is an iterative process and interaction between risk managers and
risk assessors essential for practical application (Article 9), Codex Alimentarius Commission
(CAC) 2005: 102. The NRC’s ‘Red Book’ is emphatic on this point: ‘The importance of
distinguishing between risk assessment and risk management does not imply that they should
be isolated from each other; in practice they interact, and communication in both directions is
desirable and should not be disrupted’ (National Research Council 1983: 6). 32 A more differentiated and elaborate proposal (offering and discussing alternative options) for
putting framing and evaluation on a formal footing is presented in Vos and Wendler 2007: 67-
116 Marion Dreyer and Ortwin Renn
70. One of the major differences between the proposed options refers to the mandate of the
‘interface committee’: while one option would imply that the committee deals with all food
safety cases, one of the alternative options would mean that the committee deals only with
specifically challenging cases. 33 Ibid. 34 In all cases it should be the responsibility of the European Commission to take the decision
over the need for additional participatory processes. 35 For this conceptualisation cp. Ely et al. 2007: 11-12; on these concepts see also: Stirling
2006: 225-272; Stirling, Renn and van Zwanenberg 2006: 284-315; Klinke and Renn 2002:
1071-1094. 36 This table is drawn from Dreyer, Renn, Ely, Stirling, Vos and Wendler 2007: 97.
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precautionary governance of food safety: integrating science and
precaution in the social appraisal of risk’, in Fisher, E., J. Jones and R.
von Schomberg (eds.), Implementing the Precautionary Principle.
Perspectives and Prospects (Cheltenham/Northampton: Edward Elgar),
284-315.
Stirling, A. (rapporteur) (2006), From Science and Society to Science in Society:
Towards a Framework for ‘Co-operative Research’, Report of a European
Commission Workshop, Governance and Scientific Advice Unit of
DG RTD, Directorate C2, Directorate General Research and
Technology Development, Brussels, 24-25 November 2005.
Stolwijk, J. A. J. and P. F. Canny (1991), ‘Determinants of public
participation in management of technological risks’, in Shubik, M.
(ed.), Risk, Organization, and Society (Dordrecht/Boston: Kluwer), 33-
48.
Some Suggestions for a Structured Approach 121
Turoff, M. (1970), ‘The design of a policy delphi’, Technological Forecasting and
Social Change 2: 2, 84-98.
Vos, E. (2000), ‘EU Food Safety Regulation in the Aftermath of the BSE
Crisis’, Journal of Consumer Policy, 227-255.
Vos, E. and F. Wendler (2006), ‘Food Safety Regulation at the EU-Level’, in
Vos, E. and F. Wendler (eds.), Food Safety Regulation in Europe: A
Comparative Institutional Analysis (Antwerp: Intersentia), 65-138.
Vos, E. and F. Wendler (2007), ‘Legal and institutional aspects of the General
Framework’, in Dreyer, M., O. Renn, A. Ely, A. Stirling, E. Vos and
F. Wendler (2007), A General Framework for the Precautionary and
Inclusive Governance of Food Safety. Accounting for Risks, Uncertainties and
Ambiguities in the Assessment and Management of Food Safety Threats,
Interim Report of WP5 of SAFE FOODS, DIALOGIK, Stuttgart, 4
May 2007.
Webler, T., D. Levine, H. Rakel and O. Renn (1991), ‘The Group Delphi:
A novel attempt at reducing uncertainty’, Technological Forecasting and
Social Change 39, 253-263.
Chapter 4
Innovative Approaches to StakeholderInvolvement in Risk Governance. Lessons from TRUSTNET IN ACTIONEuropean Research Project
Gilles Hériard Dubreuil and Stéphane Baudé Mutadis, Paris
Introduction
The TRUSTNET European Network (1997-2003) was set up as an attempt
to bring a fresh and pluralist approach to the severe difficulties encountered
by decisions on risks for public health and environment within the European
Union. It relied from the very beginning on a co-expertise process involving
the various categories of concerned players and stakeholders. Its work
focussed on the actual decision-making processes supporting hazardous
activities throughout their lifetime, both practical aspects and governance, as
well as in relation to the quality and practicability of those decisions in the
eyes of the actors involved. It identified a new approach to managing
hazardous activities based on a more inclusive, participatory regime that
opens up decision-making to concerned people and organisations. In 2000,
124 Gilles Hériard Dubreuil and Stéphane Baudé
the concept of inclusive governance was introduced into the Trustnet
framework as an attempt to rethink and improve the nature of the
relationship between public authorities, experts and stakeholders in the
context of hazardous activities.
Building on the work of the TRUSTNET network, the TRUSTNET
IN ACTION (TIA) European project1 was started in 2003 with the
objectives of exploring new roles and relationships of mutual trust amongst all
categories of actors involved in risk governance and of developing and testing
structures for active participation. The project involved a multidisciplinary
team of experts and researchers (law, risk assessment, ethics, economics,
sociology, political sciences, philosophy, psychology) from 17 institutions
across Europe.2
At the root of the TRUSTNET network was the understanding that
the classical approaches to decision-making in European countries had
difficulty in providing European citizens (and more specifically those at the
local or territorial level who had to live with the results of decisions on risks)
with the ability and means to actually contribute and influence decisions in
the context of activities entailing risks straddling areas of serious concern
(such as the environment, human health, economic development). It was also
acknowledged in particular that the main difficulties lay in the inherent
characteristics of classical decision-making and regulatory processes. Thus,
there was a need for sustainable changes towards inclusive governance
involving the appropriate institutional and procedural instruments as well as
new roles and relations for the various categories of players. It was also
recognised that the current processes of stakeholder engagement should be
valued to the extent they they contributed to the production of sustainable
changes towards inclusive governance.
TIA therefore examined factors that would enable sustainable progress
towards inclusive risk governance in such situations. It focussed particularly
Innovative Approaches to Stakeholder Involvement 125
on nine innovative processes taking place in seven Member States of the
European Union3 at the local, regional and national level that were
characterised by the implementation of innovative participatory features of
governance. These processes share a dimension of innovation as they
constitute a break with the traditional governance methods. They are, in
essence, experimental tools developed in order to cope with the complexity
of local, national and European situations, which bring together a range of
interrelated factors (e.g. health, economic development, environment,
preservation of resources …) that cannot be handled in isolation.
These processes were not closed cases and continued to evolve to
varying degrees throughout the TIA project. They existed before TIA was
initiated and are not therefore an artefact of the project. There was no prior
assumption that the approaches developed in the nine innovative processes
were more or less efficient or ‘successful’. The aim of the analysis was to learn
from what the stakeholders themselves understood to be successful or
unsuccessful.
The methodology of the project continued the TRUSTNET approach
of involving experts and stakeholders in the analysis of activities and in the
development of thinking. The analysis has been iterative, dynamic and
inclusive. Regular exchanges between the experts and researchers carrying
out the project and the stakeholders involved in the nine innovative processes
allowed the latter to influence the framing of the research process, making
both important contributions to the outcomes and allowing them to take
advantage of the thinking and experience developed in the course of the TIA
work.
TRUSTNET IN ACTION has enabled a new model of inclusive
governance to be constructed that represents an evolution of previous
approaches. That new model of governance is now no longer concerned
solely with local decision-making or the nominal involvement of stakeholders
126 Gilles Hériard Dubreuil and Stéphane Baudé
in decision-making; rather it involves the full engagement of local actors as
full, permanent and influential players in inclusive governance of activities or
situations entailing risks or impacts on health or the environment.
This Chapter presents three particular aspects of the outcomes of
TRUSTNET IN ACTION. The first aspect is the identification of key
features of the philosophy of governance that underlies this inclusive
governance model. The second point developed in this article is the
characterisation of the societal and institutional evolutions that support
change towards inclusive governance of activities entailing risks for health or
the environment. Finally, specific methodological patterns that support
sustainable evolutions towards Inclusive Governance will be presented. They
are referred to as ‘Cooperative Inquiries’ and are characterised by a double
perspective of aiming both at the production of reliable knowledge for action
and at the creation of the conditions that enable concerned local actors to
become full democratic players in the longer term.
Innovative Approaches to Stakeholder Involvement 127
Box 1: The nine innovative processes of TIA
Participatory biomonitoring in Belgian Flanders The bio-monitoring-campaign in Flanders investigated the relationship between environmental pollution and health effects. Answers to important questions concerning the relationship between the bio-monitoring and local situations were sought through local discussion groups in order to start up a dialogue about the campaign.
Participatory management of industrial pollution in the city of Brescia, Italy The city of Brescia suffers from long-standing pollution from toxic substances derived from industrial production and which pose serious risks to health and the environment. The municipality, stimulated by the action of a local citizens group, has set up a process to encourage the participation of all stakeholders and affected citizens in risk analysis and management.
Implementation of Local Committees for Information and Dialogue (CLICs) in the vicinity of industrial Seveso sites, France As a result of the Toulouse catastrophe of 21st September 2001, a new law on risk prevention introduced the creation of ‘Local Committees for Information and Dialogue’. The aim is to promote debates on technological risks among the stakeholders and increase transparency in the decision-making process related to risks from ‘Seveso’ industrial sites.
Sustainable management of fish stocks in the South West of England: Invest in Fish Invest in Fish South West is the first project in the UK to undertake a co-operative approach between environmentalists, fishing industry and other stakeholders and it seeks to find solutions to current fishing challenges through consensus, collaborating with those most affected by the fishing industry.
Sustainable development, including the protection of wild bears in the Haut Béarn, France The Haut Béarn Heritage Institution (IPHB) was established in 1994 in a situation characterised by a local dispute between conflicting social demands, amongst which local sustainable development was a key issue, as was the preservation of wild bears. In order to integrate these different issues into a single decision-making process, the IPHB was established as a participatory institution involving all the concerned local, regional and national stakeholders.
128 Gilles Hériard Dubreuil and Stéphane Baudé
Developing a cooperative framework for occupational health in Great Britain: Securing Health Together (SH2) The Health and Safety Executive, the UK regulator for health and safety in the workplace, has realised that its current strategy for reducing work-related illnesses would struggle to meet this goal, in particular because of the challenges in reaching smaller companies. To improve collaboration, the Securing Health Together initiative was launched to increase stakeholder participation by setting up groups to tackle specific issues relating to occupational health.
Further development of societal risk policy in the Netherlands The Netherlands has developed an extensive policy distinguishing between the protection of individual citizens against harm and the protection of society against disastrous events. The latter part of the policy came under renewed scrutiny after tragic events in Enschede and Volendam. The Dutch government has embarked on a nation-wide discussion on how to build on the existing policy to improve the structure of decision-making in this field. The Vienna Airport Mediation Process, Austria The authorities in charge of organising the extension of the airport asked an Ombudsman agency to set up a mediation process involving people from the local area. The mediation structure involved interest groups (including operators and authorities). The process led to a contractual engagement between the different parties involved.
Community Cooperation for Industrial Site Zoning, Germany The main objective of the dialogue process is to design a joint initiative allowing the communities to operate as part of a joint venture one or several industrial and commercial parks and to share the costs as well as the tax revenues. A Round Table with the 24 mayors and other stakeholders has been formed to develop a mutually acceptable solution for this new inter-community cooperation project.
Innovative Approaches to Stakeholder Involvement 129
An Emerging Philosophy of Inclusive Governance
The TIA model of inclusive governance relies on a particular philosophy of
governance that is grounded on a robust intellectual and academic premise.
This philosophical approach can be divided into four main areas: Philosophy
of Governance, Concrete Humanity, Experimental Democracy, and
Pragmatic Methodology.
Governance
Governance, in the meaning developed by TRUSTNET, is not a substitute
for traditional ‘nation-state’ government; rather it is an alternative regime
applicable to a wide range of activities and organisations. According to
Rosenau, ‘Governance is a more encompassing phenomenon than
government. It embraces governmental institutions, but it also subsumes
informal, non-governmental mechanisms whereby those persons and
organisations within its purview move ahead, satisfy their needs, and fulfil
their wants’ (Rosenau 1992: 1-29).
Gerry Stoker (see Stoker 1998: 17-28) identifies five aspects of
governance: (1) Governance concerns a range of organisations and actors, not
all of which belong to the government sphere (2) It modifies the respective
roles and responsibilities of public and private actors as established in
traditional paradigms of policy-making (3) It involves interdependence
between organisations and actors engaged into collective action in contexts in
which none of them has the necessary resources and knowledge to tackle the
issue alone (4) It involves autonomous networks of actors (5) A key principle
is that actions can be pursued without necessarily possessing the power or the
authority of the State.
The aim of the inclusive governance processes in TIA is to restore
citizens’ ability to influence decisions in order to allow them to bring about
changes, and to lead an enjoyable life by contributing to the sustainable
130 Gilles Hériard Dubreuil and Stéphane Baudé
development of their territoriality-based community. Through inclusive
participation, to be differentiated from the principle of subsidiarity, inclusive
governance empowers concrete persons to become actors at the various local,
national and European levels in the structures where decisions are taken that
will influence their life and future.
In TIA, hazardous activities may be considered as a paradigm of the
public/private conception as set out by Dewey, since these activities have
consequences outside their perimeter. The principle of precaution is a means
for opening a way into the risk issues monopolised by the experts and for
changing technical/economic issues into political issues.
Concrete Humanity
The concept of concrete humanity sees human beings as neither purely
rational nor purely irrational. They are multi-dimensional beings whose
tendencies and needs cannot be reduced to a single dimension of existence
nor to a single form of rationality. This view of humanity suggests that, as
both natural and social beings, men and women are always in search for a life
balance, that is for an equilibrium of their experiences, abilities and feelings.
However, although risks are inherent in all social and economic structures
within which people live, events or situations that critically increase the level
or degree of such risks can seriously disrupt people’s life balance. People are
essentially vulnerable beings both physically and mentally, and normal
development depends on balancing the various aspects of people’s behaviour
and personality.
Identity is an important component in that development. Identity
building processes articulate several dimensions from the most local ones
(family, village, district, region) to the most global ones (country, Europe,
mankind). Identity, however, is much more than a nostalgic communitarian
claim opposing novelty and calling for a defence of immutable traditions; it is
Innovative Approaches to Stakeholder Involvement 131
also an imaginative individual and collective structure that enables people to
have a continuity of experience and to build a meaningful life.
The pictures of mankind emerging from the TIA process are obviously
very diverse; however, all of them merge to the figure of a concrete person as
opposed to the abstract person of the technocrats, the planners or the utopists.
The concrete person is someone who articulates and adapts the multiple
dimensions of his/her identity, his/her personality and his/her existence,
which are rooted in a territory provided with a peculiar nature and culture.
The existence of a ‘concrete person’ is the outcome of a life rooted in a local
community, in close interaction with a natural and cultural environment, and
which has developed through meaningful experiences, whether constructive
or destructive, creating a special relationship to (and vision of) life and the
world.
Experimental Democracy
Democracy is a political regime in which the organisation and the exercise of
political power within society are an outcome of the will and the control of
the people. Democracy can be direct, or indirect (where the ideal of citizens’
participation in public affairs is often limited by a system of representation
based on some constraining requirements e.g. competence, reputation,
heredity). It could be suggested that ‘real’ democracies are in fact a
combination of participation, deliberation and representation.
The concept of experimental democracy is not far from the thinking of
the American philosopher Dewey, for whom democracy is less the political
form of a regime than the method by which the people can deal with the
consequences of actions; such consequences can be direct or indirect
depending on whether people are associated, or not, with the initiating
actions. On this basis, the public consists of ‘all those who are affected by the
indirect consequences of transactions to such an extent that it is deemed
132 Gilles Hériard Dubreuil and Stéphane Baudé
necessary to have those consequences cared of’ (Dewey 1927). The state then
is a consequence of the will of the people; through their representatives, it
takes care of the negative consequences of the others’ actions. A key tool in
such experimental democracies are social inquiries, which enable society ‘to
bring conflicts out into the open where their special claims can be seen and
appraised, where they can be discussed and judged’ (Dewey 1935).
The concept of experimental democracy in TIA means that the
requirements of democracy in terms of the deliberation and participation of
the citizens apply potentially to any field (science, technologies, morals, law
etc) that can be of interest to the public. It involves in particular, as in Latour
and Callon’s approach (see Latour 2004 and Callon, Lascoumes and Barthes
2001), cooperative mechanisms that gather together citizens and experts and
through which citizens can stretch and influence socio-technical decisions.
However, experimental democracy is not limited to technical issues, neither
is it merely radical as in Habermas’ approach (see Habermas 1989 and
Habermas 1996), because citizen engagement is not only experienced
through social communication, but is also expected to be included within the
institutional structure of power.
Pragmatic Methodology
Experimental democracy engaging concrete persons requires the use of a
reflexive pragmatic methodology to address the complex issues (in particular
risk issues) that impact upon multiple aspects of people’s actual life. This
methodology involves citizens, civil society organisations and other
stakeholders (local communities, interest groups etc), working together with
an inter-disciplinary group of scientists and experts through processes of
cooperative inquiry (see section 3) to investigate a problem which matters to the
public. Such processes that mingle ‘experts-scientists’ and ‘experts-citizens’
represent a modern version of Dewey’s ‘social inquiry’ and allows the
complexity of the issues under investigation to be addressed.
Innovative Approaches to Stakeholder Involvement 133
Thus, the relations between the expert and the public must be changed
so that the experts are ‘ordinary servants’ of the public; they then become just
one set of participants among many, following up a process of governance
that has its own dynamic and whose goals are shaped by the actors. The aim
of expertise is therefore no longer solely the production of valid knowledge,
but, if possible by means of a ‘double culture’, is also to build up a common
understanding with the other actors engaged in the process. This collective
work must be meaningful for both the other actors and the experts and must
reinforce, through an ethics of research, the link between science and
humanity. The aim, then, is not to produce objectivity, but subjectivation,
that is to say the emergence of a subject who can again be an actor within his
own life and within the life of his territory, and can participate in the
definition of the common good.
Change towards Inclusive Governance: A Joint
Evolution of Civil Society and Institutional and Legal
Frameworks
The nine governance processes followed in TIA (see Box 1) were not only
considered in terms of how they were organised and taken forward, but also
in how they addressed or took into account the broader context (e.g.
institutional, territorial, historical, cultural) in which they were set. They have
all been initiated by local actors and NGOs or by regional or national
institutions. They were all characterised by their precise (but often limited)
objectives, by being time limited (with a clear starting point and, usually, end
point), by the engagement of stakeholders, by the involvement of professional
facilitators and by the use of other tools to encourage participation.
The institutional changes observed in the context of the nine
governance processes were in pursuit of different goals: balancing competing
dimensions within a complex issue (e.g. risks prevention versus development
134 Gilles Hériard Dubreuil and Stéphane Baudé
of economic activities), improving the informational and cognitive basis of
the decision-making process, enhancing the quality of public policies and
decisions in terms of efficiency, legitimacy, transparency and accountability.
Governance processes such as the ones considered in TIA do not
operate in isolation of other processes in society; they both contribute and are
influenced by broader and longer Processes (with a capital ‘P’) of evolution of
their social, cultural, political, legal and institutional context. These broader
Processes may both influence and be influenced by specific experimental
processes (with a small ‘p’) of inclusive governance that thus contribute to a
more global and longer term evolution towards inclusive governance beyond
their specific remit and objectives.
This more global evolution towards inclusive governance of activities
or situations entailing risks involves both transformations of the legal and
institutional context and transformations of the territorial context. The cross-
cutting analysis of the nine governance processes demonstrates that sustainable
change towards inclusive governance necessitates, on the one hand, the
emergence of structured entities from civil society (concrete people and
communities sharing a democratic culture) rooted in a kind of territoriality
(see section 2.2) and that are becoming sustainable, autonomous and
influential players in the public and private decision-making processes that
drive the innovation process at local, national and international levels. It
involves, on the other hand, the actual transformation and opening up of
traditional knowledge-building and decision-making processes, as well as the
setting of inclusive regulatory and institutional frameworks at local, national
and European levels in order to meaningfully support and integrate societal
participation. Theses two aspects are complementary and constitute two
different facets of a single co-evolution process.
It is important to note that the cross-cutting issues described hereunder
do not constitute a description of the reality of each of the nine processes
Innovative Approaches to Stakeholder Involvement 135
considered in TIA. They are however rooted in the reality of these processes
as they are composed of elements extracted from the description and analysis
of the nine processes; these elements have been found to be paradigmatic
points, be they present in the some processes or be their absence identified as
a problem in other ones. The following elements are not a predictive tool.
Rather they aim to draw out key dimensions of the development of inclusive
governance in Europe and in doing so, to reflect both the commonalities
between the nine processes and their diversity.
Transformations of the Legal and Institutional Context: Making Room
for Permanent, Competent and Influential Engagement of Civil Society
The cross-cutting analysis of the nine innovative processes involved in TIA
allowed a great number of difficulties, resistance to change and limits that
represent an obstacle to sustainable change towards inclusive governance to
be identified. Inclusive processes have often been considered in the past by
decision-makers as a way of solving problems but from the perspective of
returning to traditional governance as soon as the crisis is over.
A gradual transformation from traditional regulatory systems (based on
centralisation, prescriptive decision-making, with a heavy reliance on experts)
towards a more inclusive system of governance, which involves in most cases
legal and institutional changes, is, however, noted in the processes considered
in TIA. This may be observed in processes where the main players in the
traditional systems (public authorities and experts, Government) were the
main drivers of change, often as a result of previous crises. Institutional and
legal issues also play an important role in inclusive governance processes
when triggered by local or regional actors, who may challenge the existing
traditional system of regulation and decision-making or whose vulnerability
may stem from the rigidity of the existing institutional framework. The
institutional and legal context and its evolution thus represent a key
dimension for the analysis of inclusive governance processes.
136 Gilles Hériard Dubreuil and Stéphane Baudé
The major contribution of the observed changes in legal frameworks
and institutional settings is to give a statutory position to the contribution of
stakeholders in the decision-making process, leading to the redefinition of
roles of stakeholders and local actors and of their relationship with traditional
decision-makers. This evolution in law and institutions also represents a
resource for autonomous stakeholders (in particular local stakeholders) to
stretch public decision-making processes. Ensuring that stakeholders take part
in decision-making processes is a key issue.
The changes observed in the institutional and legal frameworks reveal
three underlying trends: a movement from prescriptive to procedural
regulations, the establishment of favourable conditions for the engagement of
local actors and stakeholders in policy- and decision-framing (including
having access to public expert institutions), and the development of multi-
level institutional frameworks that allow for the devolution of decision-
making to territorial entities.
The first trend is a move from regulation by establishing what is to be
done to fixing, in some cases by law, the way the different actors in the
various levels will take decisions together. This move towards procedural
regulation involves in particular resorting to experimentation in the field of
public policies and in the participation of stakeholders; the latter may occur
both upstream, during the process of definition of the laws or regulations, and
downstream, in the assessment of experience of experimental phases of the
decision-making process or in the implementation of the regulations. Such
experimental approaches may include the development of ‘sunset laws’ with a
restricted period of existence.
The second evolutionary trend is a change in the legal or regulatory
provisions that allow a greater role for local actors and stakeholders in policy-
and decision-framing at the regional, national and international levels. This
evolution of institutional frameworks may include the creation of
Innovative Approaches to Stakeholder Involvement 137
consultation bodies that involve the participation of a diversity of local
stakeholders at higher levels of decision-making. In the opening up of public
legal and regulatory frameworks to local stakeholders, the governance system
takes into account the needs and perspectives of actual life in the territorial
localities. These participation mechanisms thus differ from some form of
lobbying, since local actors engaging in decision-framing at upper levels of
any decision cannot focus only on local or specific interests. They need to be
contributing to comprehensive and practicable decisions balancing all
dimensions at stake while incorporating the actual characteristics of their local
context. They appropriate and contribute to framing higher level objectives
and perspectives, while keeping proximity with the local level, thus bringing
into the decision-framing process an integrated view of the complexity of
their context and of the various interrelated dimensions at stake at the local
level.
A more specific trend is the gradual opening up of public expert
institutions to societal engagement practices in order to meet societal
demands for reliable, unbiased and transparent information and an active role
of citizens in the construction of knowledge, in particular in the field of risks
and environmental issues. These new practices run from a demand for better
access of stakeholders to counter-expertise to joint knowledge building and
fact-finding involving experts and stakeholders.
The third trend of evolution is the development of multi-level
institutional frameworks involving devolution to territorial entities for taking
and adapting elements of decisions in their specific context. This trend is
complementary to the development of mechanisms integrating the
participation of local actors into decision-making processes belonging to
higher levels. In effect, various kinds of issues, notably in the field of risks,
cannot be dealt with by dispatching them among different levels of decision-
making in a fragmented way. Through such multi-level institutional
138 Gilles Hériard Dubreuil and Stéphane Baudé
frameworks, the higher level of regulation retains the capacity to bring global
constraints into consideration at local level, but allows those constraints to be
adapted by local actors to the specificities of their context. A development of
multi-level structures of regulation, or a need for such structures, is thus
observed in the processes followed-up during the TIA project. These multi-
level structures may rely on ad hoc or permanent bodies and processes
involving local actors from concerned (in the broader sense) territorial
communities as well as other stakeholders (Public Authorities, public
expertise bodies, NGOs, Industry, etc). They are either created by local
governments to address territorial issues (in particular regarding risks and/or
sustainable development), or by law for the overall national territory. The
mandates of such bodies vary from simple consultation to decision-making
with a devolution of responsibilities previously belonging to higher levels of
decision-making or a sharing of responsibilities between local level and other
levels through a joint body. Beyond the local scope of their mandate, they
may also have a mission to advise national authorities on the elaboration or
update of laws or regulations.
These observed evolutions towards stakeholder engagement at upper
levels of decision-making and towards multi-level governance frameworks go
beyond the traditional concept of subsidiarity that is associated with a strict
dispatching of issues among the various levels of decision-making. In effect,
they provide room for actors involved at different decision-making levels to
address together issues that have impacts at the different levels of decision-
making. Such evolutions allow, in particular, the involvement of local actors
in the regulation of risk issues (traditionally addressed at national or
international levels) instead of regulating for them and in their absence
(where upper levels decisions are often then perceived by local actors as taken
against them). Through such multi-level frameworks, the local actors
involved not only adopt their own local perspective, but also act as global
Innovative Approaches to Stakeholder Involvement 139
actors sharing common stakes and concerns with other local actors as well as
with the national or international decision-makers. Such multi-level
frameworks are also characterised by a proper articulation of participatory
decision-framing with legitimate public and private decision-taking processes,
thus reinforcing their legitimacy.
In the longer term, these evolutions of the regulatory and legal
frameworks are translated into the development of corporate governance of
public institutions, in order to allow different categories of societies to
influence public policies.
The opening up of public regulations and institutions to stakeholder
engagement also entails the development of adapted public resources to
support the participation of stakeholders. These resources also need to include
access to expertise capacities of public institutions and access to co-expertise
and counter-expertise processes.
Transformations of the Territorial Context: New Patterns for
Democratic Actions for Territoriality-based Communities
The second aspect of evolution towards inclusive governance, which is
complementary to the first one, is the territorial dimension, with the
observed emergence and influence of territoriality-based communities. In effect,
in several innovative governance processes considered in TIA the change in
the modes of governance is not initiated by public authorities, but by existing
or emerging local community groups rooted in territoriality. In these
processes, individuals and their community regain control of their life and
future by integrating security, environment and economic issues in the
context of a sustainable quality of life on their territory. These communities
develop a vision of their territory that integrates an intergenerational
perspective balancing preservation of cultural heritage and traditions with
necessary updating and change in the light of life needs.
140 Gilles Hériard Dubreuil and Stéphane Baudé
The notion of territoriality at stake goes beyond local or geographical
areas, and beyond administrative entities. It involves a social construction of
territoriality that is problem-sized or project-sized and constitutes a resource
for common actions. The concept of territoriality may thus be defined as “a
set of relations which allow groups to claim their interest in space” (see cf.
Baillo and Béguin 1990) or as a “continuous or discontinuous space made by
an individual or a group for their interactions and fitting a need for its
identity and security” (see cf. Eyles 1971). The physical territory involved
represents only one dimension of the mobilised resources. In any case,
geographic and administrative structures and boundaries do not necessarily
correspond to the nature of the problem affecting a group of actors.
The concept of territoriality-based communities characterises open
modern communities relying on territoriality. This concept may be opposed
to the one of an autarkic (or self-sufficient) community. In effect, it includes a
capacity to establish links with higher levels of decision-making and with
other communities, thus recognising and valuing existing dimensions of
multi-level dependency that are inherent in modern societies. Territoriality-
based communities may also be opposed to feudal (or top-down) political
systems, in particular by their capacity to negotiate common goals and actions
between various actors outside hierarchical relationships.
One of the key characteristics of the territoriality-based communities
observed in the innovative processes followed up in TIA is the capacity of the
various engaged actors to establish horizontal connections and to cooperate
(horizontal connectivity). These horizontal connections involve a plurality of
territorial actors (local elected representatives, local NGOs, lay people,
professionals, workers, trade unions, local administrations, etc) in a position of
steady dialogue and mutual respect. Horizontal connectivity also involves a
fruitful articulation of representative democracy and participative democracy.
This articulation is not a given, but results from the experience of local actors
Innovative Approaches to Stakeholder Involvement 141
(including the experience of conflicts). Conversely, a lack of articulation of
these two complementary levels of democracy (or the absence or weakness of
local debate) may represent a destabilising factor favouring tensions and
conflicts at local level. The notion of horizontal connectivity also includes the
capacity of the various actors belonging to the community to define agreed
goals and strategies to achieve a common development project.
These territoriality-based communities are also characterised by their
capacity to embrace complexity through a local perspective that avoids
fragmentation of the actual issues at stake between specialised administrative
sectors (e.g. economy, health, environment, safety, etc), or the reduction of
complex issues to one dimension. This local perspective allows a coherent
and dynamic understanding of problems, which involves all the interrelated
dimensions at stake and integrates experience from the past with a perspective
for the future of the community. Addressing complexity encourages a much
broader co-framing of the decisions with various local stakeholders through
existing or new and ad hoc dialogue tools. Such co-framing processes allow a
richer exploration of all the dimensions of the issues at stake, and strengthen a
shared common perspective. The decisions that are achieved through such
co-framing processes are improved in the sense that they entail a plurality of
views and therefore of knowledge, a proximity with an actual complex
situation, and a capacity for feedback and flexibility. Finally, such co-framing
also improves the legitimacy of trade-off decisions that balance economy with
security, precaution and environment, in the context of both short and long
term perspectives.
A last key characteristic of territoriality-based communities is their
capacity to develop ‘vertical connectivity’. This capacity of connection with
higher levels is very important, since organising local democratic debates
while at the same time depriving local actors of influence at the higher levels
of decision-making that may severely impact local life creates frustration and
142 Gilles Hériard Dubreuil and Stéphane Baudé
scepticism about democracy itself. Vertical connectivity is about connecting
with issues and actors that belong to higher levels (regional, national,
European, international). A condition for local actors to have effective
influence on higher levels of decision-making is their capacity to translate
local concerns into issues of common interest at the higher levels and to
adopt a global perspective that gives them the legitimacy to participate in the
co-framing of regulatory frameworks and public policies at those higher
levels.
From this perspective, the objective of the participation of local actors
in higher levels of decision-making is neither to promote one interest nor to
seize the power, but to ensure that emerging multi-level governance systems
continuously stick to the complex and dynamic aspects of real life of people
in the territory. The capacity of territoriality-based communities to establish
vertical connections also involves their ability and desire to network at the
national, inter-territorial level or international level and to connect and gain
influence at higher levels. Such strategies of networking have the aim of
modifying the balance of influence between local and higher levels, in which
local actors have traditionally not always been welcome or recognised as
legitimate actors. In effect, the opening up of legal and institutional
frameworks described in the first cross-cutting issue is not a natural trend and
might necessitate resorting to political and legal conflicts.
Patterns of Pragmatic Processes for Change towards
Sustainable Inclusive Governance: The ‘Cooperative
Inquiries’
As a result of the TIA work, it is possible to formulate a hypothesis of the
existence of a process pattern that is opening up a path for change towards
inclusive governance of activities entailing risks. These processes have been
Innovative Approaches to Stakeholder Involvement 143
called ‘cooperative inquiries’. Their characteristics have been drawn both from
aspects of the nine innovative processes investigated by TIA and from the
TIA methodology itself as it evolved over the life of the project.
It is not suggested however that there is a single ‘cooperative inquiry’
model; rather, each inquiry or process has to be designed and then developed
according to its context and to the opportune moment (kairos) at which
action should be initiated. However, the TIA project has enabled the
identification of key transversal methodological characteristics of cooperative
inquiries as processes of a new type that mingle contributions of ‘experts-
scientists’ and of ‘experts-citizens. Such governance processes create the
conditions for local actors to become mutatis mutandis permanent players in
democracy beyond the window of each specific inclusive process. From this
perspective, cooperative inquiries could represent in the future a major driver
for sustainable change towards inclusive governance.
Key Characteristics of Cooperative Inquiries
Cooperative inquiries aim both at producing reliable knowledge for action
and at creating the conditions for those concerned local actors to become full
democratic players in the longer term. An important distinction is therefore
to be made between processes that are referred to here as cooperative
inquiries and forms of passive citizen participation or involvement that are
mainly aimed at improving the knowledge basis of decision-makers (who are
then expected to produce any change). In cooperative inquiries, it is rather
the growing influence of concerned local actors that is gradually expected to
create the conditions for change. A new articulation between distributed
knowledge and co-action of various actors is considered here beyond the
classical idea that good decisions are to be produced by decision-makers
provided with good information.
144 Gilles Hériard Dubreuil and Stéphane Baudé
Processes of cooperative inquiries involve a demonstrable pragmatic
methodology that has both a scientific, heuristic and strategic dimension. The
scientific dimension involves the collective inter-disciplinary co-examination
and co-validation of the quality and reliability of knowledge. It makes use of
methods of collaborative and dynamic analysis of living cases. It produces
knowledge according to scientific standards while reinforcing the reliability of
this knowledge in the eyes of the actors involved. This focuses attention on
how citizens and stakeholders are involved and how they contribute to the
collection of information, to its interpretation as well as to the development
of the methodological approach of the inquiry.
The heuristic dimension means that the methodology allows those
involved to build their own approach to evaluating the situation at stake and
the governance framework involved. The actors engaged in the cooperative
inquiry process therefore develop by themselves their own understanding of
the considered issue in the perspective of their concerns, interests and values
and eventually reframe this issue. This heuristic dimension also involves
reflexive assessment of the cooperative inquiry methodology by the actors
engaged as well as regular feedback.
The strategic dimension is the most important. The methodology
produces a subjectivation of both stakeholders and experts: stakeholders and
more specifically local actors are empowered to become active players in the
process and beyond in the broader political context at local, national and
international levels in order to regain control of their lives and future.
Beyond methodological aspects, setting up a cooperative inquiry seems
to require an individual or an institution with legitimacy and authority (moral if
not legal) to start off the process and to get the engagement of a critical mass
of key parties.
Cooperative inquiries also require the involvement of facilitators and
methodological experts (more often than not the same people) supported by
Innovative Approaches to Stakeholder Involvement 145
professional methodological standards. Professional inputs in cooperative
Inquiry processes, in terms of effectiveness, efficiency, fairness and
competency, appear to be a key factor for enabling the actual influence of
local actors on decision-making processes. It is also noted that the professional
facilitators often see themselves as change managers, recognised as bearing
democratic values, beyond their technical role in a particular process. The
facilitators and methodological experts are key players within the cooperative
inquiries; they contribute their own critical assessment of the process as such,
how it has developed, the challenges it has faced and how far it contributes to
sustainable change towards inclusive governance. Bringing together all these
views in an iterative, reflexive and inclusive process helps to draw out the
strengths and weaknesses of each process.
Traditional public engagement has often focussed on a particular issue
according to the specific remit or interest of the decision-taker. A degree of
stakeholder fatigue is noted as soon as public engagement becomes an
ordinary tool in the hand of decision-makers, and one which is often applied
outside people’s day to day concerns.
On the contrary, cooperative Inquiries are observed to be lay actor-
driven rather than issue- or principle-driven processes. The result is that such
processes are people focussed (concentrating on their issues of concern such as
quality of life). They adopt a meaningful integrated perspective embedding
security, precaution, health, environment, long term with economic and
development issues. Local actors are searching for life equilibrium and
therefore integrating the various dimensions of decisions. In this perspective,
they represent in the decision-making process a different position from that of
the classical action, interest or lobby groups that are more specifically
committed to representing and pursuing one interest or one perspective.
The existence of feedback and evaluation procedures as well as visible
evidence for the influence of stakeholder participation is a key factor of
146 Gilles Hériard Dubreuil and Stéphane Baudé
stakeholder motivation. Beyond the consequence of each specific cooperative
Inquiry process, a major dimension of this impact is, as described above, its
contribution to changing the wider institutional and territorial context.
It should be noted that the methodological skills and know-how
supporting inclusive governance need to be further developed by active
research and experimentation; this means continuing to test specific
methodologies, grounded, as suggested, in the active participation of the
concerned categories of local actors.
The TIA Methodology: An Example of Cooperative Inquiry
A structure for the TIA methodology was established at the start of the
project, with some room left for evolution and adaptation during the life of
the project. Indeed, a key characteristic of the methodology was that it
allowed, and encouraged, an open and on-going questioning of that
methodology.
The structure of the project involved on the one hand a contractually
engaged core group of experts and researchers (including the facilitators of the
nine innovative processes considered) and, on the other hand, the very nine
innovative processes at stake, including their stakeholders, who have
participated freely and voluntarily. In addition to these two key components,
the project involved a steering committee4 composed of both researchers and
stakeholders, some of them being involved in one of the TIA innovative
processes.
The aim of this structure has been to encourage extensive interaction
and two-way communication between the core group of researchers and
experts and the stakeholders engaged in the innovative processes; this
encouraged the stakeholders to have a stake in the TIA project as well as in
their own process. A cycle of annual events (meetings of the core group,
annual seminars gathering all participants including stakeholders engaged in
Innovative Approaches to Stakeholder Involvement 147
the innovative processes, and annual steering committee meetings) over the
three years of the project was established to provide a basis for knowledge
sharing and review of the progress and of the methodological approach. In
addition to the more set piece meetings, there were also ad-hoc meetings and
virtual meetings via the internet.
It was recognised from the outset that there had to be a flexible and
pragmatic approach to the methodology as findings emerged and as
participants gave feed back on their experience of the process. This flexibility
also allowed the project to take into account unexpected events or situations.
In particular, this flexibility allowed the project to adapt in the light of
stakeholder concerns and made it possible for stakeholders to play an active
part not just in the analysis but also in the development of the methodology;
this meant that at times the Core Group had to reconcile its aspirations with
those of the stakeholders.
Several approaches have been developed to gather and analyse
knowledge about the nine innovative processes considered in TIA; these
approaches included:
- involving protagonist groups in the collection of information,
- undertaking site visits so that territorial aspects could be fully
explored,
- involving all categories of participants in presentations on the
innovative processes so that views could be questioned and
challenged,
- processing feedback from the analysis of individual processes via
templates to aid the gathering of complete descriptions of the
processes.
This iterative- and stakeholder-driven approach resulted in the identification
of critical pieces of information.
148 Gilles Hériard Dubreuil and Stéphane Baudé
The TIA methodology constitutes an innovative ‘Actor-Based
Methodology’ that goes beyond case-based method relying on past return of
experience. TIA was looking at living and evolving processes where the
information was not necessarily clear cut; indeed it was often uncertain,
fuzzy, noisy and incomplete. The methodology used constituted a continuous
and in vivo cooperative investigation carried out by the core group of experts
together with stakeholders engaged in the processes considered. It involved
considerable effort to identify facts, build collective narratives, handle
controversial aspects of situations, etc. The active and practical engagement of
the stakeholders all along the research process made a unique contribution to
this and allowed preserving and highlighting the complexity of the nine
innovative processes considered.
It has to be recognised that the application (and evolution) of the TIA
methodology was not, in practice, necessarily comfortable for the participants;
but that constructive discomfort helped significantly, for example, in an
increasingly focussed acquisition of quality information about the nine
processes and in the progressive elaboration of the outputs of the project
including the global reflection about inclusive governance.
Conclusions
The TIA project brings the work of the TRUSTNET network to a
conclusion; in its ten years, it has moved from examining the control of risks
from major hazards to looking much more broadly at the role, and
importance, of inclusive governance in decision-making concerning a much
wider range of activities that entail risks for people, their life balance or the
environment. This work demonstrates the benefits and need to further
develop inclusive governance as a means for lay people in the European
Innovative Approaches to Stakeholder Involvement 149
Union to regain control on their lives and future and to influence in this
perspective the decisions that affects their lives or environment.
The problem is ‘How?’ since our current democratic systems have not
been conceived for this. The ambiguity of today’s trend for public
participation lies in the fact that, in most cases, it is not associated with actual
changes in traditional behaviour of public and private decision makers. Not is
it strongly connected explicitly with the actual decision-making processes. It
is often no more than a crisis management tool that is left aside as soon as the
crisis is over while decision-makers restart ‘business as usual’. Opening the
gates to an actual and sustainable influence of people necessitates more than
occasional participatory processes. It entails an actual transformation of
decision-making and regulatory systems. It also entails the spreading of a
democratic culture in the population that can only result from a gradual self-
empowerment and cannot be dictated. It entails changing roles and
boundaries for both public and private activities and actors.
The TIA results offer a good picture of the societal evolution and the
necessary transformations of the legal and institutional design that would
support the actual and sustainable implementation of inclusive governance.
The diagnosis made by the stakeholders and the TIA Core Group reflects the
current state of risk governance in the EU (at local, national and European
level). A great number of difficulties, resistance to change and limits have
been identified that represent major obstacles to a sustainable change towards
inclusive governance. A possible path for change has however been identified
with the ‘cooperative inquiries’ that aim both at producing reliable knowledge for
action and at creating the conditions for those concerned local actors to become full
democratic players in the longer term. Future experimentation and research will
further investigate this hypothesis. Should it be confirmed, cooperative
inquiries could represent a major driver for sustainable change towards
inclusive governance.
150 Gilles Hériard Dubreuil and Stéphane Baudé
Parliamentary democracies have not been designed overnight. Inclusive
governance will necessitate creativity, invention and most importantly:
‘experimentation’. This trend is not seen here as a revolution but more as a
gradual transformation that will evaluate, adapt or complement the existing
organisation of democracy and will fruitfully articulate participation and
representation. Such transformation is expected to reconcile science and
humanity, putting people at the heart of innovation and change in order to
orient it and give it a shared meaning.
There is a clear need to give more space for experimental approaches to
inclusive governance, to provide more opportunities for those involved in
such approaches to share experience and to develop methodologies that
increase the capacity of individual actors to play a full and effective role in
such processes. The TIA Framework, including the methodology used,
provides a robust platform for such experimentation.
Work to promote inclusive governance needs, however, to be about
much more than research; its future development now needs a political
imperative from a diversity of actors at the territorial, national and European
level. Such imperatives can take the form of actual initiatives in inclusive
governance as well as campaigning. Making explicit their motivation, the
participants of the TIA project have expressed their will: “To belong to a
community of persons that operate for Human Beings to be at the heart of debates
rather than things or economy” and “To develop a European culture to stimulate
people’s interest in issues affecting them, thus allowing them to gain influence and to
form a critical mass of engaged people throughout Europe that could provoke actual
change”.
The 2006 International Conference on ‘Sustainable development of
territories and risks governance: participatory governance for Europe’ held in
Dunkirk, France (5th and 6th October 2006) could be seen as the starting point
for such a network. This conference has gathered a pluralist group of about
Innovative Approaches to Stakeholder Involvement 151
200 actors involved in activities or situations entailing risks for people or the
environment across Europe (local and national NGOs, policy makers at
national and European level, regional and local governments, industries,
experts and researchers). The Dunkirk Appeal of 6th October 2006 has
suggested the creation of a ‘European Laboratory of Sustainable Territories’ in
order to develop, federate and support the active experimentation in Europe
of Inclusive Governance of activities and situations entailing risks and impacts
for mankind and the environment. European and national public institutions
should now actively consider how such networks can be promoted in future
and how the knowledge and know-how stemming from experimental
processes can be further disseminated.
Notes 1 The European Commission (DG Research) has funded both TRUSTNET and TIA as
Concerted Actions. For more extensive information about TIA, see the project website:
<www.trustnetinaction.com>. 2 Administrative Science Studies and Research Centre (CERSA, France), Centre Ethics
Technology and Society of ICAM Lille (CETS, France), Dialogik (Germany), Health and
safety Executive (HSE, UK), Institute for organisational communication (IFOK, Germany),
INERIS (France), Haut Béarn Heritage Institution (IPHB, France), Institute of International
Sociology of Gorizia (ISIG, Italy), Nuclear Evaluation Protection Centre (CEPN, France),
Mutadis (France), National Institute for Public Health and the Environment (RIVM,
Netherlands), University of Aberdeen (Scotland), University of Antwerp (Belgium), University
of Maastricht (Netherlands), University of Stuttgart (Germany), University of Vienna (Austria),
and the European Commission Joint Research Centre. 3 Austria, Belgium, France, Germany, Holland, Italy and the United Kingdom. 4 The Steering Committee was composed of representatives of the Health and Safety Executive
and Health and Safety Laboratory (HSE & HSL, UK), the University of Aberdeen, the
152 Gilles Hériard Dubreuil and Stéphane Baudé
University of Stuttgart, the University of Vienna, the National Radiation Protection Institute
(IRSN, France), the Regional Development Agency of Neckar-Alb (Germany), the Pro-
Natura NGO, CEPN (France), the European Commission (DG Research), the European
Commission Joint Research Centre and Mutadis (France).
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Dewey, J. (1927), The Public and Its Problems (New York: H. Holt & Co.).
Dewey, J. (1935), Liberalism and Social Action (New York: Prometheus
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Habermas, J. (1989), The Structural Transformation of the Public Sphere: An
Inquiry into a Category of Bourgeois Society (Cambridge: Polity Press)
Habermas, J. (1996), Between Facts and Norms: Contributions to a Discourse
Theory of Law and Democracy (Cambridge MA: MIT Press).
Latour, B. (2004), Politics of Nature: How to Bring the Sciences into Democracy
(Cambridge, Mass: Harvard University Press).
Rosenau, J. N. (1992), ‘Governance, order, and change in world politics’, in
Rosenau J. N. & E.-O. Czempiel (eds.), Governance without government:
order and change in world politics (Cambridge: Cambridge University
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Stoker, G. (1998), ‘Governance as a theory: five propositions’, International
Social Science Journal 155, 17-28.
Chapter 5
A Europe of Lay People: A Critical Assessment of the First EU Citizens´ Conferences
Laurie Boussaguet and Renaud Dehousse1 Centre for European Studies, Sciences Po, Paris
Introduction
Much of the literature on new modes of governance in the EU stresses the
importance attached to their participatory nature. ‘Inclusiveness’ is a defining
characteristic of the new generation of policy instruments: the actors affected
by a policy decision are to participate in its elaboration and possibly in its
implementation (See eg. Heritier 2002). While this trend can be discerned in
all democratic systems, it is of particular relevance for the European Union,
which is seen as particularly weak in terms either of parliamentary
representation or of political accountability (Smismans 2006). The European
institutions themselves have stressed the importance of participation, by
which they generally refer to the involvement of ‘stakeholders’ or ‘civil
society organizations’ (See e.g. Commission 2001). As the EU has gradually
got involved in the area of risk regulation, in which the scientific and
technological components of policy choices is prominent, they have paid ever
greater attention to the wide range of techniques developed in technology
154 Laurie Boussaguet and Renaud Dehousse
assessment as the faith in the positive effects of scientific and technological
developments began to decline (Joss and Bellucci 2002; Abels 2007).
Most of these techniques, however, assume a degree of self-
organization on the side of the participants, who must elect to define
themselves as stakeholders, organize themselves to protect their interests, and
often struggle to secure a degree of recognition. Our interest in this Chapter
is for another kind of instrument of ‘participatory technology assessment’
(PTA), in which the key actors are lay people. By lay people, we refer to
ordinary citizens, who may express him or herself in the public arena and
participate in debates and socio-technical decision-making side-by-side with
academics, specialists, and experts, despite the fact that they do not enjoy
specific expertise in the area at issue.
Dialogue with lay people is conceived of as a way of counterbalancing
the elitist character of representative democracy. This type of participation
may take place in different ways. First, it may occur in the form of vocal
participation, where lay people seek to mobilize various forms of support,
including public opinion, to make their voices heard by political powers. To
this end, they turn to unconventional political participation (petitions,
boycotts, street protests etc.). A second method of participation consists of
organized participation with experts, where lay people establish contacts with
professionals or experts. In such ‘hybrid forums’ (Callon, Lascoumes and
Barthes 2001), both contributions coexist, support each other, mutually
enrich each other and seek to express themselves via the traditional channels
of lobbying and campaigning. The third and final possibility is the participation
that is solicited, even institutionalized, by public authorities. In this case, it is the
political authorities who choose to consult them and, through this, recognize
and legitimize their participation. Several measures have been envisaged by
the legislator and/or empirically adopted to further this type of participation,
such as public surveys, the creation of a national commission for public
A Europe of Lay People 155
debate in France, the implementation of citizen consultation committees, the
organization of public hearings, or the summoning of citizen juries (Banthien,
Jaspers and Renner 2003).
Consensus conferences, or citizens’ conferences as they are also called,
generally belong to this third category and thus may be added to the long list
of measures conceived by the public powers to attempt to include citizens in
the decisional and political process. Created to foster deliberation and public
debate on disputed issues, they place ordinary citizens in the spotlight and ask
them to express their views after having debated the issues with specialists.
Whereas the conferences conducted in a domestic context have been
analyzed (see e.g. Joss and Durant 1995; Boy and Bourg 2005), little attention
has been given so far to the first attempts to replicate the experience at the
European level, and to the specific problems that may be encountered in so
doing. In the first part of this Chapter, we will examine the reasons that have
led to the development of citizens’ conferences and the way in which they
are generally organized (section 1). The second part will be devoted to the
reasons that have prompted the EU to pay interest to this participatory
mechanism (section 2) and to the structure of the first EU citizens’
conferences (section 3). Finally, we will discuss some of the problems that
have arisen in the framework of these transnational deliberation processes
(section 4).
Citizens’ Conferences (CCs) as an Instrument of
Participatory Democracy
The idea of citizens’ conferences first appeared in the medical field of the
United States in the late 1970s to help define reference practices for doctors.
The concept as we know it today took its particular form and meaning in the
field of public decision-making from a Danish experiment in 1987. Launched
156 Laurie Boussaguet and Renaud Dehousse
by the Danish committee for technology, the idea of citizens’ conferences
was designed to aid in resolving the problem of genetic technologies in
agriculture and industry. It was then that lay people were first invited to
discuss major issues with the experts. The Danish Board of Technology
defined the experimental concept as follows: ‘a consensus conference may be
described as a public enquiry at the centre of which is a group of 10-16
citizens who are charged with the assessment of a socially controversial topic
of science and technology. These lay people put their questions and concerns
to a panel of experts, assess the experts’ answers, and then negotiate among
themselves. The result is a consensus statement which is made public in the
form of a written report at the end of the conference’ (Joss/Durant 1995: 9).
Since that time, the same experiment has been repeated across Europe
and in the United States. More than one hundred such consensus conferences
have taken place, most often centered around topics related to medical and
biotechnological issues (‘national consensus conferences on plant
biotechnology’ in the United Kingdom; ‘Bürgerkonferenz Streitfall
Gendiagnostik’ in Germany; ‘citizens’ conferences on genetically modified
food’ in Denmark; ‘genetic testing’ in the Netherlands; or the ‘conférence sur
les OGM et les plantes transgéniques’ in France). Other issues have also been
addressed; for example, a conference was held in Denmark on the topic of
transportation and traffic in the city of Copenhagen, and Norway has held a
similar event on the relationship between the elderly and communication and
information technologies. In the context of the Aarhus Convention, (June
1998) which encourages ‘access to information, public participation in
decision-making and access to justice in environmental matters’, citizens’
conferences were conceived of as a tool for public debate that would put the
principle of participation into practice. The objectives were twofold: to give
citizens a say in public policy choices and to clarify the decisions made by the
elite.
A Europe of Lay People 157
In the PTA literature, several arguments are proposed in an attempt to
justify this resort to ‘participatory democracy’, incarnated by the CCs. First,
there is a democracy argument: faced with the crisis in representative democracy,
the development of a public debate is seen as a way to perfect the
participatory dimension of democracy. Citizens’ direct involvement in the
decision-making process is encouraged to counterbalance the lack of
transparency and public discussion that is said to characterize the ‘ordinary’
political process. The citizens’ conferences are perceived as a means of
facilitating the exercise of public reason by reintroducing transparency and
deliberation in the decision-making process. The principles upon which these
conferences rest – which will be described in the following section- aim to
ensure a truly democratic deliberation. In particular, they make an effort to
avoid any ‘pollution’ of the debate by partisan considerations, while ensuring
a balance between the different opinions. This is facilitated by the fact that
the participants in those processes will not be in charge of implementing the
solutions they propose, which is perceived as a guarantee of neutrality. The
absence of any direct stake in the question at issue is indeed one of the
criteria used during the selection process, in order to ensure their impartiality,
thereby facilitating the emergence of a truly common interest. At the same
time, however, the exchange of opinions that would precede any decisions
taken is perceived not as a substitute for representation, but rather as a useful
complement to it.
Secondly, there is a functional argument: in an increasingly burdened
scientific and technological context, controversies extend beyond the
scientific field and require that the societal impacts (on the society or the
environment, for example) of specific decisions be considered. Such impacts
being generally uncertain, the citizens’ conferences are seen as an innovative
way of determining the general interest on the basis of preliminary scientific
information. This helps to explain why such conferences flourished in the
158 Laurie Boussaguet and Renaud Dehousse
domain of socio-technological controversies centered on such issues as
genetically modified foods, gene therapy, foodstuffs regulation, nuclear issues
or neuroscience.
Proximity is a third argument used to justify resort to this type of
experiment. Citizens’ conferences have been often organized to debate such
territorial problems as the installation of high-voltage lines in a village, the
burying of nuclear waste, or the development of city transportation. In these
cases, we are dealing with local issues which, in contrast to the national issues
previously mentioned, can be influenced by what has been termed ‘interested
knowledge’ (Boy and Bourg 2005; Boy, Donnet Kamel and Roqueplo
2000): the people implicated in this process are generally directly affected by
the problem that has been raised, which may alter the quality of deliberation
and the conference results.
Finally, an educational argument is also frequently put forward.
Participatory procedures are often perceived of as an instrument capable of
educating citizens: they allow them to become more aware of potential
threats to their standard of living and connect the population with the
potential consequences of individual behaviour (in particular for that which
may harm the environment and put the well-being of future generations at
risk).
It is interesting to note that, participatory democracy being fashionable,
the developers of certain techniques have felt it useful to trademark them, the
declared objective being to avoid any misuse thereof. Thus, Professor James
Fishkin from Stanford University, who developed another participatory tool,
known as the deliberative poll, has registered it (Boucher 2005). Similarly,
America Speaks, a non-profit organization that promotes citizen involvement
in public policy decisions, has developed and registered a method called the
‘21St Century Town Meeting’. It was used inter alia to consult 4 500 citizens
from New York City and the region on what was to be done with the
A Europe of Lay People 159
Ground Zero site following the September 11 terrorist attacks.2 Despite theses
attempts at normalization, there remain variants in the organization of
citizens’ conferences. However, a number of recurrent organizational aspects
can be discerned in the experiments conducted so far.
The conferences are organized over a period of between 6 to 8
months, based on a public or private initiative taken by a sponsor – generally
the authority holding decision-making powers in a specific area, which will
delineate the objective of the conference and designate, in part, the steering
committee, which is then integrated into the executive body of the conference.
Composed of specialists in the subject at issue, this committee must fulfill two
essential tasks: the recruitment of lay people and the selection of instructors.
Three criteria determine the selection of the panel of instructors, which is
responsible for the preliminary training of participating amateurs: the
pedagogical quality of its members, their competence in the pertinent field,
and the extent of their involvement in the issues to be discussed (which is
measured by a study of their convictions and declarations of interest). One of
the major contributions of the citizens’ conferences to decision-making lies in
the belief that knowledge is an essential prerequisite for the debate: the
objective of the preliminary training is thus to partially reconstruct a balance
of information by endowing amateurs with enough knowledge to allow them
to ‘question’ the beliefs of the experts. At the conclusion of the training
session (which usually extends over a period of two weekends), amateurs are
aware of having gained enough knowledge to be able to formulate new
questions – questions other than those that society has asked spontaneously
concerning the technical objective to be analyzed – and to enter into a
constructive dialogue with the experts.
As for the lay participants, they may be recruited in various ways:
although the ‘call for applications’ procedure had been favoured during the
first citizens’ conferences, it rapidly appeared that it had an elitist bias. Now
160 Laurie Boussaguet and Renaud Dehousse
recourse is frequently had to a professional polling organization for the
selection of the panel of lay people. Although a representative cross-section of
the entire population is generally out of reach, as this would require the
recruitment of large numbers of people, the larger socio-demographic
features of the population as a whole may be represented by defining
diversification criteria (age, sex, cultural level, profession, residence). Added
to this initial selection is a brief questionnaire focused on attitudes so as to
ensure that the ideological balances of the panel (political and religious beliefs,
attitudes towards the issue of the conference, etc.) are respected. The panel so
constructed may not be a representative cross-section in a statistical sense (the
individuals concerned are usually motivated and interested, which separates
them from the normal profile of the average attitude), yet the separation from
the rest of the population remains less than it would be in a situation in
which self-selection was used.
This panel is assisted in its work by facilitators. These are qualified
professionals (most often in the field of psychology or other related
disciplines) who are familiar with the techniques of group moderation. Their
role is indispensable in several different ways. During the first stage of
training, they are responsible for helping some of the amateurs (in particular
those with a weaker level of education) to ‘familiarize themselves’ with the
tasks requested of them. They are also supposed to convey the ‘culture’ of the
consensus conferences to the lay people involved. Facilitators must also
ensure the openness of the debates by allowing each participant to express
him or herself and by controlling any potential tensions that may arise during
the course of the debate, since there are often large socio-cultural differences
amongst the members of the panel.
Finally, the last ‘institution’ of the citizens’ conference is that of the
panel of experts. Its members, generally between 15 to 25, are chosen by the
participant lay people, usually with the help of the steering committee, at the
A Europe of Lay People 161
conclusion of the second stage of training. The term ‘expert’ takes on a
broader meaning here: it may describe both an academic specialist in the
subject area of the conference, as well as an individual representing the
opinions of the various stakeholders (administrative, political, industrial,
associated militant, etc.). The aim of the panel is to represent all of the
interests and opinions present during the debate, so that all points of view
may be taken into consideration during the exchange of views with the lay
people.
162 Laurie Boussaguet and Renaud Dehousse
Figure 1: Flowchart of a ‘citizens’ conference’.
Recruit
Select
LAY PEOPLE The conference itself brings together the ordinary citizens and the experts.
SPONSOR
STEERING COMMITTEE (Executive of the conference) 5 to 10 members experienced in: - The techniques of the debate - The topic to be debated
PANEL OF EXPERTS - 15 to 25 chosen by the participating lay people, most often upon a proposal by the steering committee. - Clearly representative of all interests and opinions present during the debate.
At the conclusion of the conference, the lay people deliberate freely and formulate an opinion that is publicized at a press conference.
PANEL OF LAY PEOPLE - 10 to 15 participants, who are sociologically diverse - Recruited by a polling organization - Aided by a moderator
PANEL OF INSTRUCTORS - Chosen by the steering committee - Expert and educationalist - Representative of the diverse opinions/interests
A Europe of Lay People 163
In practice, a citizens’ conference is a long-term process which may be
divided into several phases:
- Phase 1: The sponsor launches the initiative; a steering committee is
formed and recruits a panel of instructors and a panel of lay people.
- Phase 2: Two training sessions for the lay participants are organized
(usually over the course of two weekends) and taught by the panel of
instructors, at the conclusion of which the lay people choose the
panel of experts.
- Phase 3: The conference itself takes place publicly and brings
together the lay people and the experts, who debate over the theme
of the conference. The debate is usually divided into several different
sessions.
- Phase 4: The lay people deliberate in a closed-door session in order
to formulate an opinion or recommendations.
- Phase 5: Their opinion is made public during a press conference.
- Phase 6: An external evaluation procedure is launched a posteriori,
made possible in particular by video recordings taken during the
training sessions and the debates.
When all is said and done, three main criteria make these conferences truly
unique (Boy and Bourg 2005): the contribution of knowledge (which
distinguishes the conferences from opinion polls, for example); the closed-
door deliberation, designed to avoid any potential pressures (in contrast with
simple consultations); and the search for a balance at all levels: within the
steering committee, the panel of instructors and amongst the experts. CCs are
therefore an original approach, allowing citizens to deliberate on a subject
before a decision is made in the hope of improving the quality of decisions
and the legitimacy of decision-makers.
164 Laurie Boussaguet and Renaud Dehousse
Why Europe is Interested in a Dialogue with Lay
People
For the European Union, the recent beginning of dialogue with lay people is
part of a two-fold evolution. On the one hand, the European institutions
increasingly intervene in the field of risk regulation, in order to determine the
response that is best adapted to scientific and technological challenges. On the
other hand, the European institutions have been searching for ways to
establish direct links with the citizens over the past 15 years as an attempt to
respond to the recurring criticism of the lack of democracy in EU decision-
making.
That Europe has been able to play an increasingly preeminent role in
risk regulation should not be surprising, as this evolution is a corollary of the
functionalist strategy presiding over integration since the launch of the
European Coal and Steel Community. One of the key aspects of European
integration has been the establishment of a large market, within which goods,
services, individuals, and capital may be allowed to circulate freely. Yet
putting a market of continental dimensions into place does not merely
presuppose the removal of barriers to free movement. Each time that
fundamental interests are protected at the national level, the preservation of
the acquired level of protection may only be achieved in two ways: either by
tolerating the maintenance of national ‘protective’ legislation (as is
occasionally permitted by the Treaty of Rome3), or by harmonizing
protection rules. The latter solution offers the advantage of avoiding any
distortions in the conditions for competition. Unsurprisingly, it has long been
the preferred solution of the European Commission as well as the member
states with the most advanced regulation: both pushed for a massive
intervention on the part of the Community and then the European Union in
such fields as environmental and consumer protection, workplace health and
safety, or public health (Héritier 1994). In other words, as Giandomenico
A Europe of Lay People 165
Majone observed at a very early stage, despite the deregulatory outlook of the
1992 programme launched by the Delors Commission, it contained the seeds
of a re-regulation movement at the European level (Majone 1990).
This logic led to a progressive extension of European competencies via
the Single European Act as well as the Maastricht and Amsterdam treaties,
and to a constant development in European legislation within the field that
can be broadly defined as ‘risk regulation’. This trend was accelerated by a
series of crises in such areas as food safety (the mad cow crisis) or marine
pollution (the Prestige and Erika shipwrecks). To a growing extent, Europe is
thus a level towards which citizens as well as economic operators tend to turn
whenever their interests are at stake (Majone 1996).
This gives rise to new questions, since intervention in these particular
fields often implies mastering complex scientific and technological issues that
often go beyond the expertise available within the European institutions. The
Court of Justice has established, in principal, the need to consult experts
where necessary in order to ensure the fulfillment of the protection aims of
Community legislation.4 The Treaty of Amsterdam followed in this path by
requiring the Commission to take into account ‘all new evolutions based on
scientific facts’ when formulating its proposals in the area of health, safety,
environmental and consumer protection.5
These requirements are based on a classical division of tasks between
scientists and political leaders, with the former providing the latter with the
elements to make a decision based on the most up-to-date scientific
knowledge. Unfortunately, reality is often more complex and the borderline
between political decision and scientific debate is relatively porous. Science
does not always produce univocal judgments, and disagreements often exist at
the heart of the scientific community on the magnitude of a problem or on
the best way to deal with it (Godard 1997). Political leaders may thus be
criticized for rubber-stamping the opinion of selected experts. The European
166 Laurie Boussaguet and Renaud Dehousse
Commission has, for example, been brought before the Court of Justice for
having pursued the recommendations of a committee of experts concerning
the prohibition of a cosmetic believed to be cancerous.6 In other cases, the
national origins of scientists bring the neutrality of deliberations into doubt.
Thus, in its opinion on the European Union’s handling of the mad cow crisis,
the Inquiry Committee of the European Parliament painted a rather gloomy
picture of the functioning of the veterinary scientific committee, criticizing in
particular the large number of British experts within the committee.7 The
malfunctioning noted on this occasion thus led to a radical reform of the
scientific committees established by the Commission in order to guarantee
the objectiveness and transparency of their activities.8 Finally, even where
scientific assessments seem to converge, there may be disagreement as regards
non-scientific aspects of an issue. Similarly, public opinion may be reluctant
to accept new technologies, even where their dangers have not been proven,
as illustrated by the resistance to genetically modified foods or the presence of
hormones in meat.
While the uncertainties that often surround scientific evaluation may be
a problem for most contemporary decision-makers, they are magnified at the
European level by the fact that the European institutions have never boasted a
strong political legitimacy. Without entering into a theoretical debate on this
question, let us recall here that the last European elections brought only a
minority of voters out to the polls, and despite the increasing role played by
the Parliament in the nomination of the President and members of the
Commission, the voter’s preference is not directly reflected in the designation
of the executive. It is thus difficult to consider a decision to be valid simply
because it was taken by those validly chosen to do so. Thus, the quest for
alternative sources of legitimacy designed to overcome the weaknesses of
representative democracy, is of particular relevance in a political system
which finds more support in the elites than among ‘ordinary citizens’.
A Europe of Lay People 167
In a context marked by the increasing responsibilities of the European
Union in scientifically and technologically-oriented fields and by the decline
of a ‘permissive consensus’ on the benefits of integration, the interest of
European leaders in forms of participatory democracy such as the citizen’s
conference is easy to understand. This has prompted the Commission’s
Forward Studies Unit to pay attention to these techniques even before its
White Paper on Governance (Dehousse and Lebessis 2003; De Schutter and
et al. 2001) was published in July 2001. However, those concerns found only
weak echo in the White Paper. Beyond generic statements in favor of more
openness, greater involvement of civil society and the need to ensure the
integrity and pluralism of expertise, the Commission merely notes:
‘Scientific and other experts play an increasingly significant role in preparing and monitoring decisions. From human and animal health to social legislation, the Institutions rely on specialist expertise to anticipate and identify the nature of the problems and uncertainties that the Union faces, to take decisions and to ensure that risks can be explained clearly and simply to the public. The advent of bio-technologies is highlighting the unprecedented moral and ethical issues thrown up by technology. This underlines the need for a wide range of disciplines and experience beyond the purely scientific’.9
Although the White Paper did not give any indication of the method by
which an opportunity for extra-scientific considerations may be ensured, the
Commission has never ceased to pursue its quest for channels through which
lay persons may express their views. In particular, the ‘science and society’
section of the 6th Framework Programme on research and technological
development encouraged research on this subject in the hope that this would
allow participatory methodology to be tested.10 Community funds have
therefore allowed theoretical research on the role of the citizen and the
organization of the first citizens’ conferences to take place on a European
scale. It is within this framework that the first two experiments discussed
below took place.
168 Laurie Boussaguet and Renaud Dehousse
The Citizens’ Conference Experiments at the
European Level
The first citizens conference organized at the European level took place in
December 2005 within the framework of the RAISE project11 (‘Raising
Citizens and Stakeholders’ Awareness and Use of New Regional and Urban
Sustainability Approaches in Europe’). Focusing on ‘the city of tomorrow’, it
was financed by the European Commission as part of the 6th Framework
Programme on Research and Development. It was rapidly followed by a
second one, ‘Meeting of Minds: European Citizens’ Deliberation on Brain
Science’,12 dealing with the impact of new developments in neuroscience.
This conference was part of a two-year project that concluded in January
2006 with a meeting of European citizens and the public presentation of this
convention’s report before the European Parliament. Since our research was
undertaken, another two pan-European conferences have been organized,
dealing with the role of rural areas in tomorrow’s Europe13 and with the
future of Europe14 respectively. However, the remarks that follow are based
on the analysis of the first two experiments.
Objectives and Structures
At first sight, these two conferences correspond closely to the model provided
by the original citizens’ conference. Both concerned issues about which such
meetings are thought to be useful: in the first case, territorially defined issues;
in the second, a theme linked to the social implications of scientific
development.
The ‘Meeting of Minds’ involved citizens from 9 different European
countries who were invited to debate the impact of neuroscience on daily life
and on society as a whole. The aim of this project, which was coordinated by
a Belgian charity, the ‘Fondation Roi Baudouin’, was to formulate
recommendations that may help in policy formation in the fields of scientific
A Europe of Lay People 169
research and health at both the national and Community levels. The timing
was appropriate since it took place right after the launch of the 7th Framework
Programme in Research and Development and the release of a Commission
green paper on mental health.15
In contrast, the decision to hold a citizens’ conference on urban
development and the various depictions of the ‘city of tomorrow’ was
disputable. A classic scenario would organize the citizens’ conference before
legislating, since the very goal of deliberation is to enlighten the decision-
makers. However, the European Union does not have the proper jurisdiction
to take decisions in this area. Moreover, having recourse to citizens’
conferences for aspects involving urban politics is often justified using
proximity grounds since the participants are directly concerned by the
problems addressed. Yet, the situation is different at the European level,
where the questions to be debated are inevitably more abstract given that the
EU is not directly in charge of urban policy. Finally, the goal of the project
was to test earlier research findings and to persuade people to accept them:16
the questions of the conference were centered on the concept of ‘urban
sustainable development’, linked to several concrete options established by
former successful projects within the 5th and 6th Framework Programmes.17
Given these conditions, the real impact of a deliberation could only be a
limited one: the lay people of the conference were involved only at a phase
in which the implementation of pre-established principles could be discussed.
The selection of panel members is a key element of a successful
citizens’ conference. In theory, the exercise must be as inclusive as possible.
To overcome the traditional weaknesses of democracy, whose resources are
mainly used by the most well-to-do and best organized socio-professional
categories, an effort is made to recruit panel members in such a way that all
categories of society are represented. But representativeness is more an
instrument than an end in itself: it is meant to ensure that the deliberation
170 Laurie Boussaguet and Renaud Dehousse
process, which is at the heart of citizens’ conferences, is not biased by the
origins or the experience of panel members.
In this regard, the two initial conferences that we have surveyed differ
profoundly. Although they are both marked by a will to exclude experts and
professionals working in the sector in question, they also illustrate two
different conceptions of the panel of lay people and what these panels
represent.
During the conference on neuroscience (‘Meeting of Minds’), 126
citizens from 9 European countries18 (14 individuals per country) were chosen
at random by sending invitations to a number of addresses. Specific criteria,
such as age, sex, level of education and place of residence were then used to
select those individuals who would participate in the process. Each national
group needed to reflect the diversity of its country of origin. In the end, 51%
of the panel was composed of women, 65% were city residents, 31% were
between 18-34 years of age, 42% between 35-54 years and 27% were 55
years and older. The goal of this mode of random selection was to retain as
much of the diversity of the population of these nine countries as possible.
In the case of the RAISE project, the recruitment of lay people was
done via an application process. A questionnaire was posted on the project’s
website at the end of January 2005, and from the 570 applications received,
26 participants (one from each member state as well as one Romanian) were
chosen. Although the declared ambition of the project was to create a
representative panel composed of average citizens from the member countries
of the EU, the organizers themselves acknowledged that they did not fully
achieve this goal.19 An analysis of the sociological profile of the applications
received reveals the elitist nature of the selection procedure, since it shows
there was an over-representation of intellectual professions, or ‘knowledge
workers’ (lawyers, judges, translators, students, researchers, managers). In
addition, a number of candidates were living in a different country from that
A Europe of Lay People 171
in which they were born, or had lived several years outside their country of
origin. The admissions procedure (online and in English) and the constraints
related to participation in such a conference (flexibility of schedules) no
doubt contributed to these distortions. The demographic profile of the
candidates reflected this: 56% were men; only 4.3% unemployed; 44.8% lived
in a city center. Remarkably, the sociological profile of the standard applicant
was close to that of the average internet user,20 or ‘Netizen’: often male,
young, and a city dweller with a high level of education. Figures concerning
the level of education are quite telling, for the large majority (88.1%) of
candidates had a university diploma. Clearly, the initiative seems to have
attracted those individuals who may be defined as ‘true European citizens’,
being both mobile and educated.
These findings confirm what Daniel Boy had observed in his study on
citizen panels (Boy 2005: 80-85): a voluntary admissions procedure has the
effect of ‘over-selecting’ candidates (Boy 2005: 80.) and accentuating the
elitist nature of the panel. In contrast, a random selection procedure, with
well-defined criteria for diversification, may allow for the constitution of a
panel that is in sync with the rest of the population, although it will never be
a completely representative panel in a statistical sense.
The Functioning of Citizens’ Conferences
Finally, an exhaustive analysis of the experiments carried out at the EU level
requires us to focus also on the very functioning of these deliberative
meetings. At this level, the problem is not merely to bridge the gap between
lay people and experts, as is the case in ‘standard’ citizens’ conferences. An
additional difficulty must be overcome: how can a deliberation be efficiently
organized in a transnational setting, within which political cultures, traditions
and languages vary considerably? Again, our two case studies demonstrate that
different approaches can be found to tackle these problems.
172 Laurie Boussaguet and Renaud Dehousse
As we previously emphasized, one of the key characteristics of the
citizens’ conferences concerns the importance granted to appropriate?
knowledge. Training is offered to lay people in order to provide them with
the tools for analysis that allow them to converse efficiently with experts.
Although the two experiments undertaken so far at the European level have
attempted to respect this founding principle, they have nevertheless
approached the idea differently, conditioned by the choices made within each
project, the size of the panel of lay people and the difficulties surrounding the
organization of a true deliberation at the European scale.
The RAISE project followed the ‘classical’ model very closely: the
process was divided into four stages, with the first two consisting of
preparatory citizen panel workshops that could be assimilated to the training
sessions. The goal of these workshops, which took place over the course of
two days at the beginning and the end of September 2005, was to familiarize
citizens with the issues up for discussion. In particular, the workshops aimed
at providing citizens with an idea of what sustainable urban development is21
as well as a presentation/evaluation of the possible responses proposed by
current European research.22 They were conceived as indispensable
prerequisites to the third workshop, which took place in Brussels in October
2005 and during which the ‘Citizens Declaration on the European City of
Tomorrow’ was written.
The ‘Meeting of Minds’ project took a different approach, in large part
due to the magnitude of the project, which involved more than one hundred
citizens. The sequence of events was somewhat different to that above,
starting with the training stage of the lay people involved. Preliminary
information was circulated within national amateur panels via a brochure23
created as an introduction to brain sciences. The first weekend meetings were
organized at the national level in April and May 2005 for the purpose of
training the participants for the upcoming procedure. The national
A Europe of Lay People 173
coordinators and moderators presented the project to the various groups of
citizens, preparing them for the steps to follow during the next stages, and
placing great emphasis on the difficulties inherent in the organization of
multilingual and multicultural discussions. Finally, the citizens began to
explore the issue in question on the basis of the common information
brochure, and to elaborate the different points of view that needed to be
submitted to the first European convention. Thus, the project innovated to
overcome the tension that exists between the will to ensure the unity of the
deliberative process (for example, through the dissemination of a unique
brochure to the participants from different countries) and the diversity
inherent in the variety of participants’ origins and languages. This has led to
the emergence of a multi-level process, the national meetings serving as a
preliminary to the European citizen’s conference. The transnational nature of
the deliberation has thus required a reinterpretation of existing procedures.
The very agenda of the citizens’ conference also reveals a different
understanding of the ‘European’ nature of the two projects in question. In
the case of RAISE, the idea of organizing a consultation and a deliberation of
lay people at the European level does not seem to have had an impact on the
structure of the exercise: the size of the citizens’ panel (26 members) is not far
from that of conferences organized at the national or local level, and the four
stages of the project correspond to those of the traditional schema analyzed
earlier.24 However, it seems that the experts played a limited role in this
process: as the discussion principally concerned the findings and the options
proposed prior to the deliberation, the dialogue with the lay people seems to
have been a one-way conversation.
For its part, the ‘Meeting of Minds’ project made an effort to adjust the
citizens’ conference tool by taking into account the inherent requirements for
the organization of a transnational deliberation. As indicated earlier, this
project was organized on two different levels: the introductory national
174 Laurie Boussaguet and Renaud Dehousse
meetings preceded the first European convention of citizens on topics in
neuroscience (3-5 June 2005), during which a common framework for
analysis was established in addition to an initial series of questions that were
designed for the pursuit of deliberation at the national level. Following this,
national evaluative meetings, during which experts were convened, have
allowed for the preparation of the second European convention of citizens,
concluding the project in January 2006. In addition, given the size of the
citizens’ panel (126 participants in total), several original initiatives had been
planned for the organization of the two meetings that took place at the EU
level. The organizers adopted a technique used for a similar initiative in the
United States, the so-called ‘21st Century Town Meeting’ Method,25 in
which all participants assemble in a large hall in order to create a community
feeling. In the case of ‘Meeting of Minds’, however, they were divided into
smaller groups around different tables to allow for more in-depth discussion
and exchanges of opinion concerning the topic at hand. This method was
refined between the two European conventions, in particular to overcome
the language barriers that created problems during the first conference. It is in
this way that the ‘carousel method’ was implemented during meetings at the
end of January 2006: eight smaller monolingual tables encircled large
multilingual tables, like the petals of a flower. The citizens moved amongst
these tables in a complex ballet, which allowed them to alternate between
discussions in their respective languages and broader exchanges around the
multicultural table. Obviously, this requires an important logistical set-up: 75
people were recruited to help the discussions run smoothly, they were assisted
by 48 additional translators and professional moderators. However, as with
the former case study, the project received most criticism in relation to the
role of the experts. In this case, the experts did not participate until the
second phase of the process, beginning with the second series of meetings at
the national level. Some participants seem to have regretted this situation. In
A Europe of Lay People 175
an initial report presenting the overall results of the first European
convention, an Italian participant observed that: ‘the democratic process
worked well, but more expert input prior to the discussion may have been
helpful’.26
On the basis of the two experiments conducted so far, one can
conclude that the organization of such citizen deliberations at the European
level is not a straightforward exercise. It requires careful consideration of the
problems inherent in the organization of such an event at the transnational
level, as well as on the usefulness of such an instrument in a structure like the
European Union. It is to these questions that we shall now turn.
Conclusion: When can Lay People’s Participation
make a Difference?
The interest of European leaders in the participation of lay people at the
Community level, or even the consultation of these citizens concerning
certain issues, is easy to understand. In fact, as emphasized earlier, both
functional reasons – the need to take a position on a socio-technological
controversy whose stakes are controversial and the absence of a strong
democratic legitimacy at the EU level – provided incentives to explore new
ways to liaise with the European citizens.
However, achieving such citizen deliberations is not without problems,
as the two examples of European citizens’ conferences that we have analyzed
have shown. In many respects, these problems point to the difficulty entailed
in the creation of a European public space or even a political Europe. Four
key points deserve particular attention.
The elusive quest for a ‘European people’ is the first difficulty that
emerged in the two citizens’ conferences we surveyed. We clearly saw that
serious difficulties are encountered when attempting to constitute a panel that
176 Laurie Boussaguet and Renaud Dehousse
represents a microcosm of European society as a whole. The selection
techniques in themselves may contribute to the elitist nature of the panel.
Having recourse to self-selection, as in the case of the RAISE project,
introduced a bias into the panel, an overrepresentation of higher-educated
categories of the populace. In any event, it is difficult to achieve a panel that
would perfectly reproduce the various components of the European people.
As indicated above, representativeness is but an instrument; yet it is important
if one intends to ensure that a wide enough range of views are included in
the deliberation process. It would be fallacious to think that this would be the
case without due regard for the plurality of the panel.
On the other hand, the two projects studied here attached great
importance to the truly transnational nature of the lay people´s panel. This in
turn gave rise to a problem, well-known to those who have studied the
construction of a political Europe: how should countries of variable size be
represented at EU level? In both cases, a strict principle of equality was
maintained, apparently without much debate – 14 citizens per country in the
case of the ‘Meeting of Minds’; one citizen per country for the 25 member
states in the case of RAISE – as if the two citizens’ conferences sought to
represent the sovereign states. However, for all societal issues linked to the
development of science and technology (which constitutes the sphere of
election for the citizens’ conferences), we know that there may exist very
different national sensitivities. The question is to figure out whether the
weight of each of these sensitivities should be identical. Clearly, the principle
of equality risks creating an over-representation of some views to the
detriment of others. This issue, which has had such an impact on political
integration, will certainly leave its mark on citizens’ conferences. Indeed,
evidence suggests that on several occasions, participants construed their role as
that of a national representative, insisting on the fact that recommendations
put forward at the national level should be incorporated in the final
A Europe of Lay People 177
document, even when this threatened the final consensus (Renn and
Goldschmidt, 2007).
A third notable point concerns the issue of languages, a recurrent
question in discussions about a European public space. In all cases, this issue
represents an obstacle for experiments in citizen deliberations at the European
level. If one language (unavoidably, English) is be privileged in the name of
efficiency, this considerably reduces the number of potentially mobile citizens
for the conference and accentuates the elitist nature of the citizens’ panel, as
demonstrated by the RAISE example. Alternatively, a multilingual
conference may be organized, as was done during the ‘Meeting of Minds’, in
which eight languages were used during the deliberations. Yet, in addition to
the costs and logistic issues that a multilingual conference raises, such an
option may also have an effect on the content of the debates, as the project’s
coordinator explains: ‘The numbers of people were not a problem […], but
the language is really the limiting factor. Simultaneous translation with
headphones worked fine for the plenary sessions. But when the people were
holding detailed, small-table discussions, trying to express delicate ideas, some
sophistication was lost as the translators batted the conversation around’.27 As
with all issues linked to the establishment of a European public space, the
languages problem remains central for EU citizens’ conferences.
To these methodological difficulties is added a more general question,
involving possible the misuse of citizens’ conferences. Participatory
democracy has become trendy, and it may be tempting to set up experiments
whose primary impact would be mainly symbolic, namely to demonstrate the
openness of the public authorities. Without going so far as to say that this was
the case of the two experiments studied in this article, we cannot help but
notice that their influence in decision-making was bound to be limited. In
the case of the RAISE project, citizen deliberation took place only at the
stage where the implementation of previously established principles could be
178 Laurie Boussaguet and Renaud Dehousse
discussed. Moreover, both experiments were conducted in areas in which the
European institutions possessed only limited jurisdiction, and where their
decisions could therefore have at best a limited impact. One could even
envisage that citizens’ conferences could be resorted to not so much to
enlighten public authorities before they take a decision, but rather to
convince citizens of the wisdom of choices made elsewhere. This clearly
suggests that one should not fall into the temptation of regarding all of these
experiments as necessarily positive in themselves, as is sometimes the case
with participatory devices. Much depends on why and how they are used. If
citizens’ conferences are to be organized more frequently, it would be wise to
require that citizens demand, one way or another, that one should be held.
It does not follow from all this that citizens’ conferences organized at
the European level may have only a limited effect on decision-making.
Despite all of the difficulties that we have identified and the criticism that we
have formulated, one should not be unduly negative. First, the experiments
we surveyed were largely tentative, conducted in part to test a new
participatory methodology. Secondly, even if the impact of these conferences
on the decision-making process is questionable, their contribution can be
relevant. As Daniel Boy remarked (Boy and Bourg 2005), the citizens’
conference may succeed in publicizing certain problems and promoting
public debate on the chosen topics. They also allow the problem to be
analyzed from a different perspective, by taking into account points of view
that do not necessarily appear in the traditional horizon of the decision-
makers. This aspect was correctly perceived during the ‘Meeting of Minds’
project, whose declared ambition was to ‘give relevant inputs into European
policy-making and widen public debate on brain science’.28 On the other
hand, in addition to their influence on agenda-setting and decision-making,
the exchanges that the citizens’ conferences encourage may favor a shift in
the positions of the various actors involved. Even if most legislative
A Europe of Lay People 179
interventions that will follow will take place on the national level, one may
still witness a convergence in the schemas of analysis as well as in the conduct
of scientific research on the topics discussed. The advocates for reform may
find here arguments that can be mobilized in their respective countries. For
their part, national leaders may find inspiration in the conferences for the
redefinition of their policies. In other words, the impact of European citizens’
conferences should not necessarily measured by the number of European
directives that they inspire into being. Their main potential may lie in the
above-mentioned cognitive aspects.
Notes
1 Translated by Juliana Galan. Earlier versions of this article were presented at the first meeting
of French Europeanists (AFSP, Bordeaux, April 2006), at the CONNEX conference on
‘European Risk Governance: its Science, its Inclusiveness and its Effectiveness’ (Maastricht,
June 2007) and at the Meeting of Minds workshop on ‘The Challenges of Public Deliberation
at a Transnational Level’ (Brussels, July 2007). The authors thank participants in these meetings
for their comments. 2 For more details on this technique, see
<http://www.americaspeaks.org/services/town_meetings/what_is.htm>. 3 See, for example, Article 95, paragraph 4: ‘If, after the adoption by the Council or by the
Commission of a harmonisation measure, a Member State deems it necessary to maintain
national provisions on grounds of major needs referred to in Article 30, or relating to the
protection of the environment or the working environment, it shall notify the Commission of
these provisions as well as the grounds for maintaining them’. 4 Case C212/91 Angelopharm GmBH c. Freie und Hansestadt Hamburg [1994] ECR I-171. 5 Article 95, paragraph 3.
180 Laurie Boussaguet and Renaud Dehousse
6 Affair T-199/96 Bergaderm and Goupil v. Commission [1998] ECR II-2805. 7 PE Doc A4-0020/97A, 7 February 1997. 8 Commission Decision 97/404/CE of 10 June 1997 setting up a Scientific Steering
Committee, OJ L 169, pp. 85-87. 9 CEC, Commission of the European Communities, European Governance. A White Paper,
COM(2001) 428 final, 25 July 2001, Brussels. 10 Interview with Rinnie Van Est, Rathenau Institute, in charge of methodology in the
Meeting of Minds project, The Hague, 12 July 2006. The above-mentioned report concerning
the role of civil society in the Europe of research (Banthien, Jaspers and Renner 2003) is also a
product of the FP6 programme. 11 <http://www.raise-eu.org>. 12 <http://www.meetingmindseurope.org>. 13 European Citizens’ Panel, <www.citizenspanel.eu/>. 14 European Citizens’ Consultation, organized in the framework of the Commission’s ‘PlanD’
programme. See <http://www.european-citizens-consultations.eu/>. 15 CEC, Commission of the European Communities, Green Paper. Improving the mental health of
the population: towards a strategy on mental health for the European Union, COM(2005) 484 final, 14
October 2005, Brussels. 16 ‘RAISE aims at testing the acceptance and usability of results achieved by the recently closed
or ongoing EU research projects on urban sustainability’, in the project description, ‘About
RAISE’. <http://www.raise-eu.org/about.html>. 17 ‘The questions must be centred on the concept of “urban sustainable development” and they
shall be related to a portfolio of concrete options that appear to be offered by some of the 5th
Framework City of Tomorrow and Cultural Heritage Key Action research projects, as well as
by some projects on urban sustainability funded under the 6th Framework Programme’.
<http://www.raise-eu.org/conference-concept.html>. 18 Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, United
Kingdom. 19 Interview with Carlo Sessa, President of ISIS (Istituto di Studi per l’Integrazione dei Sistemi)
and coordinator of the RAISE project, Roma, 24/07/2006. 20 See, for example, the study on ‘The French and the Internet’ conducted by SOFRES in
2002. <http://www.tns-sofres.com/etudes/corporate/280302_internet.htm>. 21 ‘First Citizen Panel Workshop: Developing a vision of what “urban sustainable
development” is, using the ten Bellagio Principles. 9-10 September 2005, Vienna, Austria’.
<http://www.raise-eu.org/conference-dates.html>.
A Europe of Lay People 181
22 ‘Second Citizen Panel Workshop: Evaluation of what possible answers are provided by the
current EU-research on urban sustainable development. 30 September – 1 October 2005,
Rome, Italy’. <http://www.raise-eu.org/conference-dates.html>. 23 Meeting of minds. Food for thought and debate on brain science. Information brochure,
<http://www.meetingmindseurope.org/europe_default_site.aspx?SGREF=16&CREF=1279> 24 That is to say, the two training sessions, the citizens’ conference itself with deliberation and
the formulation of recommendations (‘Citizens Declaration on the European City of Tomorrow’),
and, finally, the public presentation of the declaration to decision-makers. 25 See supra note 2. 26 European Citizens’ Deliberation on Brain Science, June 3-5, 2005, Report on the 1st
European Citizens’ Convention, p. 6. See
<www.meetingmindseurope.org/Download.aspx?ID=269>. 27 Interview with Gerrit Rauws, director at the King Baudouin Foundation and project
coordinator, Brussels, 29 November 2006. 28 ‘What are the objectives of Meeting of Minds?’, About the project,
<http://www.meetingmindseurope.org>.
References
Abels, G. (2007), ‘Citizen Involvement in Public Policy-Making: Does it
Improve Democratic Legitimacy and Accountabilility? The Case of
PTA’, Interdisciplinary Information Sciences 13:1, 103-116.
Banthien, H., M. Jaspers and A. Renner (2003), Governance of the European
Research Area: the role of civil society. Final report (Berlin/Bruxelles:
Bensheim).
Boucher, S. (2005), ‘Démocratiser la démocratie européenne. Quelles voies
pour une délibération inclusive et transnationale de qualité’, Notre
Europe, Policy Paper n°17.
182 Laurie Boussaguet and Renaud Dehousse
Bourg, D. and D. Boy (2005), Conférences de citoyens, mode d’emploi: les enjeux
de la démocratie participative (Paris: C.L. Mayer/Descartes & Cie).
Boussaguet, L. and R. Dehousse (2007), ‘L’Europe des profanes: l’expérience
des conférences citoyennes’, in Costa O. and P. Magnette (eds.), Une
Europe des élites ? Réflexions sur la fracture démocratique de l’Union
européenne (Bruxelles: Editions de l’Université de Bruxelles), 241-258.
Boy, D., D. Donnet Kamel and P. Roquelo (2000), ‘Un exemple de
démocratie participative: la “Conférence de citoyens” sur les
organismes génétiquement modifiés’, La Revue Française de Sciences
Politique 50: 4-5, 779-809.
Callon, M., P. Lascoumes and Y. Barthe (2001), Agir dans un monde incertain.
Essai sur la démocratie technique (Paris: Seuil).
Dehousse, R. and N. Lebessis (2003), ‘Peut-on démocratiser l’expertise?’,
Raisons Politiques 10, 107-123.
Godard, O. (1997), ‘Social Decision-Making under Conditions of Scientific
Controversy, Expertise and the Precautionary Principle’, in Jeorges,
C., K.-H. Ladeur and E. Vos (eds.), Integrating Scientific Expertise into
Regulatory Decision-Making (Baden-Baden: Nomos), 39-73.
Héritier, A. (1994), ‘Leaders’and ‘laggards’ in European clean air policy’, in
van Waarden, F. and B. Unger (eds), Convergence or Diversity?
Internationalization and Economic Policy Response (Aldershot: Avebury),
278-305.
Heritier, A. (2002), ‘New Modes of Governance in Europe: Policy-Making
without Legislating?’, in Héritier, A. (ed.), Common Goods: Reinventing
European and International Governance (Lanham: Rowman & Littlelfield),
185-206.
Joss, S. and J. Durant (eds.) (1995), Public Participation in Science. The Role of
Consensus Conferences in Europe (London: Science Museum).
A Europe of Lay People 183
Joss, S. and S. Bellucci (eds.) (2002), Participatory Technology Assessment –
European Perspectives (London: University of Westminster Press).
Majone, G. (ed.) (1990), Deregulation or Re-Regulation? Regulatory Reform in
Europe and the United States (Basingstoke: Macmillan).
Majone, G. (1996), Regulating Europe (London: Routledge).
Ortwin, R. and R. Goldschmidt (2007), ‘Meeting of Minds. European
Citizen Deliberation on Brain Science. External Evaluation’, Paper
presented at the workshop on o’The Challenges of Public Deliberation
at a Transnational Level’, Brussels, July.
De Schutter, O. et al. (eds.) (2001), La gouvernance dans l'Union
européenne/Commission européenne (Luxembourg: Office des publications
officielles des Communautés Européennes).
Smismans, S. (2006), ‘New Modes of Governance and the Participatory
Myth’, European Governance Papers (EUROGOV), n°06-01,
<http://www.connex.org/eurogov/pdf/egp-newgov-N-06-01.pdf>.
Chapter 6
The EU Chemicals Policy: Towards InclusiveGovernance?
Veerle Heyvaert London School of Economics
Introduction
This contribution analyses contemporary European risk regulation as an arena
for inclusive governance, concentrating on the regulatory regime for the
control of chemical risks. The focus on chemicals is rewarding for a number
of reasons. First, the threats to health, safety and the environment posed by
dangerous chemicals, and the abiding uncertainties surrounding the links
between chemical exposure and health and environmental degradation, have
long elicited high levels of public concern. Moreover, since the risks attach to
the product of chemicals itself, rather than to a side effect of commercial
enterprise as is the case for, say, the risks of air pollution caused by industrial
emissions, measures introduced to manage and reduce these risks tend to have
a very direct impact on the marketability of commercial wares. Thus, the
various interests that inform the shape and substance of market regulation --
ranging from competitiveness, innovation, and market stability and fairness,
186 Veerle Heyvaert
to worker, consumer, and environmental protection -- collide in chemical
risk decision-making in a highly visible and explicit way.1 Finally, since the
EU regulatory framework for the production, marketing and use of chemicals
has recently undergone a major overhaul, it offers a good insight into how
and the extent to which notions of inclusiveness are currently being
integrated into governance of the European market.
The analysis will show that, formally at least, the EU regulatory regime
for chemicals control is far more inclusive than its predecessor. However,
when looking below the surface of formal arrangements, and particularly
taking into account that the effectiveness of inclusion is determined not only
by the creation of entry points into the regulatory debate, but equally by
determinations of what is debatable, it is unlikely that the chemicals control
regime will foster effective participatory decision-making.
Before reviewing the current “REACH” regime for chemicals control,
Part II briefly goes over the salient features of the old regime, and adds some
information on its level of inclusiveness. Part III summarily maps out the key
features of the recently adopted REACH Regulation. The core of the
analysis then follows in Part IV, which examines the inclusiveness of
REACH at the different stages of “input” (i.e., participation into the
negotiation and adoption of REACH), “throughput” (participation in the
decision-making processes taking place under the REACH framework) and
“output” (participation in the critical evaluation of regulatory decisions taken
under REACH). Part V Critically reviews REACH’s provision for public
participation, in particular by extending the idea of inclusiveness to take into
account the scope and integrative structure of the regulatory framework. Part
VI summarises and concludes.
The EU Chemicals Policy: Towards Inclusive Governance? 187
The Old Regime for Chemicals Control in the
European Union
Prior to 2007, chemicals control in the EU was governed by a network of
Directives and Regulations.2 The old system operated on the basis of a
double distinction, first, between dangerous substances/preparations and
other chemicals3 and, second, between old or “existing” substances, and
substances introduced on the EU market after September 1981 or “new
substances”. The latter distinction was mostly the result of political and
economic expediency. As awareness grew throughout the 1970s that the
availability of timely and reliable information concerning the health and
environmental impacts of the release of chemical substances was crucial for
the design of a risk management framework that had a fighting chance of
effectiveness, EU institutions conditioned market access upon the notification
of a compendious technical dossier to the competent authority located in the
Member State where a manufacturer or importer first sought to market a new
chemical, or a preparation containing a newly engineered substance. In
exchange for the new information production and supply burdens,
manufacturers and importers gained a one-stop shop facility, whereby a single
notification would be recognised by all Member States.4 For chemicals that
were already in circulation however, the imposition of information supply
and testing requirements was considered too onerous and potentially
disruptive to the economy.5 Hence, during the first decade after notification
duties were introduced, EU law did not foster information supply concerning
existing chemicals in a systematic way. The notification requirement, and its
absence of a counterpart for existing substances, was a textbook example of a
regulatory control mechanism that favours the old over the new.6 In addition
to stifling innovation, the approach was undesirable from a health and
environmental protection perspective, since old chemicals tend to pose
greater risks than newer generations of substances.
188 Veerle Heyvaert
The Member State competent authority was the pivotal actor in the
notification process. Importers and manufacturers submitted technical dossiers
to the national authorities, which were in charge of checking the
completeness of the file, and circulating it to the Commission and the other
Member States for review. Furthermore, as of the early 1990s EU law
instructed national authorities to perform a risk assessment on the basis of the
information in the technical dossier, in accordance with newly enacted
Community risk assessment standards.7 The risk recommendations flowing
from the risk assessment could constitute a basis for regulatory action, either
at the Community level or, residually, at the Member State level.8 At the EC
level, such regulatory intervention would typically take the form of a new
restriction on marketing and use, adopted via legislative amendment of
Directive 76/769/EEC on the approximation of the laws, regulations and
administrative provisions of the Member States relating to Restrictions on the
Marketing and Use of Certain Dangerous Substances and Preparations
(Marketing and Use Restrictions Directive).9
As mentioned above, the situation was different for existing substances.
Very little was (and still is) known about the most of the 30,000 chemicals
that have been regularly traded since before September 1981. To address this
data gap, the Council adopted Regulation (EEC) 793/93 on the Evaluation
and Control of the Risks of Existing Substances (Existing Substances
Regulation).10 The data gathering approach established therein was distinctly
more centralised than in the framework of notification. Pursuant to the
Existing Substances Regulation, manufacturers and importers were to report
all available chemical data directly to the European Commission. The various
submissions were collected by the European Chemicals Bureau,11 established
under the auspices of the Joint Research Centre Environment Institute,
which processed everything into a comprehensive, EU-wide database
(“EUCLID”). The information in EUCLID then constituted the starting
point for a priority setting exercise. The Commission drew up priority lists
The EU Chemicals Policy: Towards Inclusive Governance? 189
enumerating those substances which, on the basis of available information,
had the highest risk potential. These substances were assigned to different
Member States for further data gathering and risk assessment. The Member
States authorities, acting as delegates to the Commission, would report their
findings back to the Commission in the form of a risk recommendation. If
the risk recommendation indicated that regulatory interventions were
necessary to control identified health and/or environmental risks, the
Commission would draft a legislative proposal for risk reduction, either under
the Marketing and Use Restrictions Directive, or under an alternative EU
regulatory framework (for instance, the Control of Chemicals Agents at
Work Directive12). In contrast to the notification procedure, which after a
few years performed reasonably well, the Existing Substances Regulation
failed to deliver. It would exceed the scope of this paper to scrutinise the
different factors that led to the failure of the existing substances regime,
however in the framework of this analysis it should be noted that the absence
of either positive or (credible) negative incentives for the chemical sector to
cooperate in the regime fatally crippled the Regulation.13 This serves as a
reminder that no matter how formally binding, rules are vulnerable. Hence,
the greater legitimacy that inclusiveness aspires to convey is not only
normatively attractive, but can crucially influence regulatory effectiveness.
As is already apparent from even a snapshot overview, the old regime
was institutionally dominated by public authorities, in the first place national
regulatory authorities (NRAs). NRAs administered the notification process,
performed risk assessments for new substances and, as rapporteurs, for existing
ones post-1993, and through the process of Council amendment were
intimately involved in the negotiation and adoption of new and tightened
restrictions. The Commission, too, played a prominent role, as it orchestrated
that data gathering and evaluation regime under the Existing Substances
Regulation and, which rather more success, formulated and adopted
harmonised classifications for dangerous substances. This representation does
190 Veerle Heyvaert
somewhat understate the inclusiveness of the old regime, particularly with
regard to the involvement of chemicals producers and importers. The
notification provisions under Directive 67/548, as amended, offered notifiers
the opportunity to prepare and submit a preliminary risk assessment.
Moreover, traders were required to formulate and affix a preliminary
classification for the dangerous chemicals they were trading. More generally,
while imposing a regulatory burden, producers’ and importers’ responsibility
for information supply, both in the context of notification and for existing
substances, simultaneously created an access point to regulatory decision-
making processes that were facilitated by data supply.14 Even though formal
guarantees were thin on the ground, the chemical sector was usually
informally and at times extensively consulted prior to, for instance, the
formulation of a harmonised classification. However, the lack of formal
provisions for participation did keep private parties dependent on goodwill
rather than entitlement, and importantly meant that parties external to the
data supply, evaluation and decision-making process, such as public interest
NGOs, had even more limited opportunities of engagement.
The preceding paragraphs offered a rudimentary sketch of the
Community approach to chemical risk regulation between 1980 and 2007.
REACH, however, has brought about a transformation of regulatory
chemicals control, and arguably even of the EU’s approach to complex risk
governance more broadly. The following sections briefly review the main
features of REACH, and then concentrate on the question of inclusiveness.
REACH
On 1 December 2006, the Environment Committee of the European
Parliament (EP ENV) and representatives of the Council of Ministers agreed
on a compromise text on REACH, the new and controversial regulatory
framework for the control of chemical substances in Europe. The REACH
The EU Chemicals Policy: Towards Inclusive Governance? 191
Regulation,15 as duly voted on by the EP plenary on 11 December and
adopted by the EP and Council on 18 December, entered into force on 1
June 2007. Its provisions will be gradually implemented over a period
spanning from now until 2018.
REACH stands for the Registration, Evaluation, Authorisation and
Restriction of Chemicals. REACH is intended to provide an encompassing
regulatory framework that enables information production and decision-
making relating to all chemicals produced and/or circulating in the EU
market,16 covering every stage of the chemicals production and use cycle.
The information allows identification of dangerous chemicals, a cost-effective
assessment of the risks posed by the production, marketing, use, and disposal
of such chemicals, and the development of cradle-to-grave risk management
policies, which must be passed on and refined through the chemicals supply
chain. The following sections give a short description of the salient features of
the REACH regulation, covering registration, evaluation, authorisation, risk
reduction, institutional design, and enforcement.17
Registration18
REACH’s philosophy is that no chemical substance, in whatever form,
should circulate on the market without adequate documentation. To this
effect, REACH imposes a generalised registration requirement: manufacturers
or importers of chemicals produced or imported in volumes of over 1 tonne
per year must apply for registration, which is conditioned on the submission
of a technical data file supplying health, safety, and environmental
information. Registration extends previous data reporting requirements19 in a
number of significant ways. Most importantly, registration targets the roughly
30,000 chemicals which have been traded in substantial volumes within
Europe for over 25 years, but for which scant or no information is available.20
Moreover, Registration affects chemicals substances as well as chemicals in
192 Veerle Heyvaert
preparations21 and in articles. This means that registration duties not only fall
upon chemicals manufacturers and importers, but also on the vast groups of
traders selling goods that contain chemicals, ranging from cars to disposable
lighters.
Evaluation22
The data gathering requirements under REACH connect to the framework’s
second risk management stage; the evaluation procedure. Evaluation covers
the evaluation of dossiers submitted pursuant to registration, which is
compulsory for those containing proposals for animal testing, in order to
minimise duplication of information. Substance evaluation, in turn, is carried
out when initial data raise suspicions concerning the health and/or
environmental impact of chemicals. An EU-wide rolling action plan will be
established, where substances targeted for evaluation are allocated to a
Member State which acts as rapporteur. Where suspicions are confirmed,
evaluation may trigger further risk management actions, such as the inclusion
of the chemical on the list of substances subject to authorisation, or the
drafting of risk reduction measures.
Authorisation23
The most controversial pillar of REACH is the authorisation requirement for
highly dangerous chemicals, such as CMRs,24 PTBs25 and vPvBs.26 After the
lapse of a sunset date, those chemicals that have been identified as subject to
an authorisation requirement can only be produced, traded and/or used if
Commission approval has been obtained. It is incumbent on the private
applicant for authorisation to furnish proof, in the form of an extensive data
file including a risk assessment and risk management recommendations, that
the risks posed by the chemical are either adequately contained, or that no
usable alternatives currently exist but substitutes are being investigated.
The EU Chemicals Policy: Towards Inclusive Governance? 193
Applications are reviewed by the newly established European Chemicals
Agency (ECHA), which produces an opinion for the Commission.
According to the wording of the REACH Regulation, if the risks are shown
to be adequately contained, the Commission must authorise. If, on the other
hand, it is impossible fully to contain the risks, the Commission may grant
authorisation, depending on the severity of the risk and viability of
alternatives. Authorisations are subject to review and monitoring.
Manufacture, Marketing and Use Restrictions27
A risk management alternative to authorisation is the adoption of
Community-wide restrictions curbing the production, marketing and/or use
of dangerous chemicals. The REACH Regulation both incorporates pre-
existing measures, which were enacted in the 1976 Marketing and Use
Restrictions Directive and ensuing amendments, and maps out the process for
the adoption of new restrictions. As with authorisation, risk reduction
measures are adopted by the Commission acting on an ECHA opinion.
Before REACH, the adoption of each new restrictive measure required
Council (and, after Maastricht, Council and European Parliament (EP))
decision-making,28 which slowed down the introduction of chemical risk
measures to the point of ineffectiveness.29 The shift towards a Commission
decision-making process is intended to speed up this process, and thus deliver
a higher level of up-to-date health and environmental protection standards.
Interestingly, the procedure designated for the adoption of restrictions is the
new ‘regulatory procedure with scrutiny’, which was introduced in a 2006
amendment to the 1999 Comitology decision.30 The regulatory procedure
with scrutiny responds to demands for greater EP involvement in
Commission decision-making.31 It is the sole comitology procedure where
agreement between the Commission and the consulted Committee of
national representatives does not automatically result in adoption of the
194 Veerle Heyvaert
Commission proposal. Instead, even Committee-approved proposals are
forwarded to the EP and the Council ‘for scrutiny’, which institutions may
oppose the proposal by simple (EP) or qualified majority (Council)
respectively. The regulatory procedure with scrutiny certainly provides a high
level of accountability of the Commission and Committee vis-à-vis the
primary EU law-makers. However, checks and balances make for lengthy
procedures, and we might wonder whether this new form of comitology will
still be able to deliver results more efficiently than the Council and EP
decision-making process which it replaces.
Institutional Design
With the new standards and procedures mapped out in REACH comes a
new institutional design to manage the regulatory framework. Most
importantly, the REACH Regulation establishes the European Chemicals
Agency (ECHA),32 which will function as both the designated supplier of
scientific expertise and opinions to the Commission, and the chief
administrator of the scheme. Whereas formerly Member State national
authorities were the first point of contact with private parties complying with
EU regulatory requirements, and thus the chief liaison with Community
authorities, applicants for registration under REACH directly submit their
applications to ECHA, which will: review registration dossiers; check the
completeness of the file and, where necessary, request additional information;
perform the registration; and assign a registration number. In the case of
applications for authorisation, applicants submit to ECHA, which then
orchestrates the scientific review of the technical file and risk assessment
submitted by the applicant, and drafts a recommendation for the
Commission. Member State involvement in the process is primarily arranged
through a permanent Member State Committee under ECHA’s auspices. As
mentioned before, the Commission takes the lead in decisions relating to
The EU Chemicals Policy: Towards Inclusive Governance? 195
substance evaluation and its outcome, and decides on authorisations, as well
as on restrictions on manufacture, marketing, and use. Member States do
however have an opportunity to be closely involved in the identification of
substances for evaluation, and perform the crucial task of substance
evaluation. Additionally, the Member State is represented in Commission
decision-making through the familiar channel of comitology.
This brief overview cannot do justice to the delicate balances and
intricacies that the institutional settlement under REACH reflects. In broad
lines, however, REACH could be said to represent an exercise in regulatory
centralisation, as both the pivotal administrative and decision-making
functions are exercised by Community institutions (respectively, ECHA and
the Commission). Also, and perhaps of even greater importance, whereas
before REACH communications between public authority and the private
sector where predominantly conducted through the intermediary of national
regulatory authorities, REACH not only enables but even requires a direct
dialogue between EU institutions and regulatory addressees. Shifting patterns
of communication can seriously affect the relationships and relative
dependencies between the various actors in a regulatory network. In the
REACH scenario, they could in the long run contribute to divert familiarity,
allegiance, recognition of regulatory practice and even authority from the
national to the European level.
Enforcement
REACH firmly embraces a policy of ‘no data, no market’. After the
transition dates, any unregistered chemical (or chemical use) should be taken
out of circulation. For old or ‘existing’ chemicals, this daunting penalty for
non-registration is precisely what distinguishes registration from preceding
data reporting duties under the Existing Substances Regulation, the failure of
which to deliver results was broadly attributed to the absence of a credible
196 Veerle Heyvaert
threat in case of non-compliance.33 Hence, the credibility of REACH as a
workable system for risk control, both within the EU and on the global
scene, will hinge largely on the effectiveness with which regulatory provisions
are enforced. This is where the role of the Member State is crucial, as
enforcement of the REACH requirements is entirely a national responsibility.
Inclusive Governance in REACH
As a prominent strand of the pervasive discourse on “good governance”
which has so dominated the last ten years of EU regulatory studies, the most
commonly understood version of inclusive governance focuses on the
question of how, and to what extent, different stakeholders get to represent
their interests and participate in the process of law- and decision-making.34
For reasons that have been thoroughly discussed elsewhere, attention tends to
centre around those stakeholders and interests that, although affected by
regulatory processes and their outcomes, traditionally had very limited
opportunities for direct engagement.35 Often, such categories of stakeholders
are loosely grouped under denominations such as “the public”, “the public
interest”, or “civil society”; terms which all construe oversimplified but
workable representations of those entities that do not have a privileged status
in regulatory decision-making by virtue of authority or specific designation in
the regulatory framework.
The analysis below follows this format as it looks at opportunities for
private stakeholders, and particularly stakeholders that are not the direct
addressees of the regulatory prescriptions in the REACH Regulation, to be
involved in the regime for chemicals risk control, in terms of its development
(input), its operation (throughput), and vis-à-vis the decisions it generates
(output).
The EU Chemicals Policy: Towards Inclusive Governance? 197
Input
The history of the REACH reform is one of extensive consultation and
debate. From its inception, , REACH was a pronouncedly high-profile
enterprise. Speaking before the plenary, Head of EP ENV Committee Karl-
Heinz Florenz called REACH “one of the largest and most significant
reports” ever to be debated within EP Chambers.36 The level of interest and
controversy surrounding the initiative was, first of all, a function of its scale,
as REACH was the outcome of a review process, started up in 1998, which
involved no less than four key pieces of EC internal market legislation:
Directive 67/548 on the Classification, Packaging and Labelling of Dangerous
Substances;37 Directive 88/379 on Dangerous Preparations;38 the 1993
Existing Substances Regulation;39 and Directive 76/769 on Marketing and
Use Restrictions for Dangerous Chemicals.40 The review process was a
prominent and early example of the Commission’s willingness to orchestrate
broad-based consultation and some level of participation in policy reform
initiatives, which obviously further raised stakeholder awareness of the
impending changes.41
Going on from there, every further step leading up to the adoption of
what would become known as the REACH Regulation, along landmarks
such as the 2001 Commission White Paper on a Strategy for a Future
Chemicals Policy,42 the 2003 release of the Commission Proposal for a
REACH Regulation,43 and a range of impact assessments to gauge the
anticipated regulatory costs and benefits of proposed risk control schemes,
was accompanied by a high level of intensive, at times acrimonious but
reasonably transparent public debate. Moreover, this debate was fuelled by an
impressive array of different actors, including domestic and non-EU chemical
industry associations, representatives of small and medium sized businesses,
consumer organisations, national EU and non-EU governments,
198 Veerle Heyvaert
environmental NGOs, trade unions, IGO and regional organisations, research
institutes and academics, etc.
It would be disingenuous to claim that the process was insufficiently
inclusive or accessible; the great pains that the Commission, for one, took
broadly to consult and respond indicate otherwise. In fact, we could very
plausibly hold up the REACH reform process as blue print for participatory
law-making. Yet, equal opportunities for access to not imply equal
opportunities for influence. Pesendorfer argued that, while consultation was
formally inclusive, the terms of the debate, and the regulatory context in
which it took place, favoured the promotion of private over public interest
perspectives, and of economic over health and environmental
considerations.44 We will revisit this connection between access to and
context of the debate when considering the impact of the scope and risk
management prescription in REACH on inclusive governance.
Throughput
A key question in examining the inclusiveness of the REACH framework,
inquires into the extent to which different interests and stakeholders are
represented in decision-making pursuant to REACH. As indicated before,
REACH comprises a range of decision-making procedures, going from
procedures to determine whether a registration is complete, and hence
whether a registration number can be assigned which validates a product’s
new or continued circulation on the EU market, to the identification of
highly dangerous chemicals that should be authorised, the authorisation itself,
and the adoption of risk reduction measures for substances that are not subject
to authorisation but nonetheless pose unacceptable risks. To gain a
preliminary insight into the level of inclusive risk governance under
REACH, this paper focuses on the interplay between institutions and
interests taken into account in the authorisation process of a substance
The EU Chemicals Policy: Towards Inclusive Governance? 199
identified as falling under the authorisation requirements. Admittedly,
authorisation constitutes but one pillar of the REACH framework; a
complete picture of the organisation and degree of inclusiveness of the
contemporary EU chemicals control regime, as an example of modern risk
regulation, would additionally require the consideration of consultation and
participation provisions in the registration, evaluation, authorisation
identification, and risk reduction processes. However, since selectiveness
cannot be avoided within the confines of a paper, the focus on the
authorisation process is warranted because this process involves the marketing
and use of precisely those chemicals that stir the highest level of public
concern. Consequently, authorisation is the regulatory process in which the
public arguably has the strongest interest in participating, and where exclusion
from decision-making is least justifiable. The authorisation procedure
therefore is a good indicator of the degree of inclusiveness aspired to under
REACH, and of the likelihood of effectiveness.
Stage 1: Application
For purposes of simplicity, we can divide the authorisation process into three
segments: the application, review, and decision stages.45 In each of the three
stages, a different player assumes the lead in the authorisation process.
Applications are formally industry-led: it is incumbent upon manufacturers,
importers or downstream users to prepare and submit the application dossier.
In practice, dossier preparation will be predominantly expert-driven, as the
central documents are a chemical safety report (or risk assessment) covering
the risks to human health and the environment from the use of the substance
arising from its intrinsic properties, and an analysis of alternatives including,
where appropriate, research and development activities undertaken by the
applicant. With regard to the chemical safety report, Annex I.0.2. stipulates
that the assessment “shall be prepared by one or more competent person(s)
200 Veerle Heyvaert
who have appropriate experience and received appropriate training”. The
chemical safety report follows the traditional science-based risk assessment
pattern of human, physico-chemical and environmental hazard assessment;46
exposure assessment, and risk characterisation. It is interesting to note that the
required description of exposure scenarios, which map out the conditions
under which the substance is manufactured and/or used, is to include “a
description of both the risk management measures and operational conditions
which the manufacturer or importer has implemented or recommends to be
implemented by downstream users”. This does create scope for existing risk
management information, which is generated and developed in a practically
applied context, to be integrated within the science-based assessment process
and influence the ultimate risk characterisation. This risk characterisation,
ultimately, compares the predicted or known exposure with the DNEL47
(human health) and/or PNEC (environmental health),48 and assesses the
likelihood and severity of an event occurring due to the physico-chemical
properties of the substance (such as explosiveness and flammability). If
exposure does not exceed the DNEL and/or PNEC, and if risks relating to
the substance’s physico-chemical properties are negligible, the risks posed by
the substance are considered “adequately controlled”, which crucially affects
the outcome of the authorisation process. However, before turning to those,
it should be observed that Article 62(5) of the REACH Regulation allows
applicants to include a socio-economic analysis in the application dossier,
which broadens the scope for alternative types of information to be
introduced early in the decision-making process.49 Similarly, the analysis of
alternatives “considering their risks and the technical and economic feasibility
of substitution”50 allows for the integration of non-scientific information into
the application stage.
The EU Chemicals Policy: Towards Inclusive Governance? 201
Stage 2: Review
The dominant player in the second or “review” stage of the authorisation
process is the European Chemicals Agency (ECHA). ECHA receives
applications directly from manufacturers, importers and downstream users,
and produces a draft opinion on whether the reviewed substance should be
authorised for (continued) sale and/or use, and on the applicable conditions
for authorisation. ECHA, which opened shop in mid-2007, and which will
gradually expand its regulatory, administrative and advisory operations to
meet all the responsibilities assigned to it in the REACH Regulation by
2010, is an independent European Community Agency, conceived and
structured along similar lines as the European Food Safety Agency (EFSA).51
Thus, at first glance the review stage of the authorisation process should be
heavily technocratic, dominated by a group of independent, unelected civil
servants located in the beautiful but rather remote Helsinki. However, to
represent the review stage as purely technocratic, and in the hands of one
monolithic institution, rather underplays the complexity of the review
process for two reasons.
First, it does not take into account the checks and balances built into
the authorisation process. Once an application is submitted to ECHA, it
forwards the application dossier to its Committee for Risk Assessment (CRA)
and its Committee for Socio-Economic Analysis (CSEA) to produce a draft
opinion within 10 months of submission. Consultation with “third interested
parties” is foreseen in Article 64(2) of the REACH Regulation. Beyond this
provision, CSEA can ask either the applicant or third parties to give
additional information on substitutes, and both Committees are to “take into
account any information submitted by third parties”.52 Once the draft
opinion is ready, the applicant is invited to comment upon it.53 If the
applicant avails herself of this opportunity, the ECHA Committees must
consider the comments before producing their final opinion. ECHA then
202 Veerle Heyvaert
forwards the final opinion, together with the applicant’s comments, to the
Commission, the Member States, and the applicant. If the applicant does not
comment, the draft opinion is confirmed as final opinion and equally passed
on to the Commission, the Member States, and the applicant.
Second, it pays to take a closer look at the institutional set-up of
ECHA, and the inclusiveness of representation within the organisation.54 In a
nutshell, the Agency is run by an Executive Director (Geert Dancet) and
Management Board of 32. Each Member State appoints a member to the
Board. Of the remaining five, two are appointed by the EP, and three by the
European Commission. The latter include one industry, one employees and
one NGO representative (without voting rights).55 ECHA’s work load will
be spread over six planned Directorates, most of which will be staffed by
scientifically trained personnel. However, Directorate A is destined to house a
unit for international cooperation and stakeholder relations, which will inter
alia be responsible for risk communication with and between the various
stakeholders. Moreover, ECHA will be assisted by three Committees and a
Forum56. The Member State Committee is the main channel through which
national interests are represented internally. Additionally there are the
aforementioned CRA and CSEA. The latter particularly would seem to
constitute a locus for non-scientific risk considerations to be integrated into
the authorisation review process.
Stage 3: Decision
Finally, the Commission heads the decision stage of the authorisation process.
It formulates a proposal on the basis of the final opinion delivered by ECHA,
which is adopted following the regulatory comitology procedure.57 As
known, the regulatory procedure requires committee approval by qualified
majority for the adoption of the proposal to go forward. In the absence of a
positive qualified majority within the committee, the Commission must
forward a measure relating to the proposal to the Council, which has the
The EU Chemicals Policy: Towards Inclusive Governance? 203
option to reject it by QMV within three months. In the absence of a Council
rejection, or if the Council comes out in favour of the Commission’s
proposal, the Commission adopts the measure. In the context of the
REACH authorisation procedure, three points are of particular interest. First,
even though it is the procedure of choice for several other implementing
mechanisms under REACH,58 the newly introduced regulatory procedure
with scrutiny (RPWS)59 is not appropriate the adoption of authorisations,
since the latter are executive measures rather than quasi-legislative
measures.60 The EP’s involvement will therefore be restricted to the alarm
bell procedure set out in Articles 5(5) and 8 of the 1999 Comitology
Decision. Second, the reference to the regulatory procedure is an amendment
to the original text of the REACH Regulation, according to which
authorisation decisions followed the advisory procedure.61 In the realm of
comitology, the advisory procedure is unequivocally the most supranational
of the implementing decision-making processes. The Commission is bound
to obtain and take account of the advice of a committee of Member State
representatives, however the Commission has the authority of adopt its
proposal even in the face of a negative committee opinion. Although the shift
from advisory to regulatory procedure was played off in the press as a minor
adjustment,62 it represents an important recalibration between the national
and supranational influences in what will certainly be the most controversial
and politically sensitive decision-making procedure under the REACH
umbrella. Finally, with regard to the substantive decision on authorisation,
the Commission’s discretion differs depending on whether the applicant can
show that the risks are “adequately controlled”. If so (in other words, if the
applicant can make a plausible case that the known or anticipated exposure
will not exceed the no-effect exposure), Article 60(2) in principle requires the
Commission to authorise marketing and/or use. The Commission only has
discretion to refuse an authorisation where risks are not adequately
controlled. In this case, the authorisation and conditions will hinge on the
204 Veerle Heyvaert
risk-benefit ratio which commercialisation of the substance represents, and
the availability of alternatives.63 It should be noted in this context that, for
many PBT, vPvB and CMR substances, it is at the moment scientifically
impossible to define a safe level.64 These fall under the category of “not
adequately controlled”, and will therefore be subject to a substitution
requirement and discretionary decision-making.
Output
What are the provisions and conditions to engage with the outcome of an
EU regulatory process, in this case, the Commission decision to approve
grant or withhold authorisation? Beyond the purely informal (though
powerful) avenue of openly praising or criticising a Commission decision in
the media, stakeholders need to resort to judicial review mechanisms. The
notoriously unforgiving nature of access to justice conditions for non-
privileged applicants (i.e., stakeholders other than the main Community
institutions, the Member States, and the party/parties to whom the decision is
addressed) under Article 230 EC has been exhaustively documented and
reviewed,65 and need not be repeated here. It is, however, useful to point out
that, in 2006, a ray of light appeared in the form of Regulation (EC) No.
1367/2006 on the application of the provisions of the Aarhus Convention on
Access to Information, Public Participation in Decision-making and Access to
Justice in Environmental Matters to Community Institutions and Bodies(the
Community Institutions and Bodies Regulation).66 As to access to
information, Articles 11 to 13 of the Regulation require the availability of
databases or registers giving information on, inter alia, authorisations with a
significant impact on the environment, thus further strengthening the
publicity requirements under the REACH Regulation.67 Moreover, Title IV
of the Regulation provides that environmental NGOs, provided they have
the qualifications spelled out in Article 10, can make a request for internal
The EU Chemicals Policy: Towards Inclusive Governance? 205
review to a Community institution or body that has adopted an
administrative act under environmental law. This provision could be relied
upon by environmental NGOs to request review of Commission decisions
pertaining to chemicals authorisations. If authorisations are indeed understood
as “administrative acts under environmental law” – and there could be some
debate about this – then the availability of internal review is indeed a further
step towards inclusiveness. However, we do need to be aware of the
Regulation’s limitations. First, it only grants review opportunities to NGOs,
and environmental NGOs at that. Other public interest groups, and private
actors operating outside of the framework of an NGO, remain excluded.
Second, the provision is for internal, not judicial review. A 2006 ECJ ruling
confirmed that the provisions of the Community Institutions and Bodies
Regulation have to be read in compatibility with Article 230 EC, and cannot
be deployed as to bypass the stringency of its provisions.68
A Contextual Appraisal of Inclusiveness
Reviewing the inclusiveness of the REACH framework at the stages of
input, throughput, and output, there is certainly some cause for satisfaction.
Broad-based consultation and debate enriched to the point of nearly
overburdening the legislative reform process. Interested third parties have an
opportunity to submit information during the authorisation process.
Engagement at the output stage is still the weak link of the governance
regime,69 but the new Community Institutions and Bodies Regulation may at
least create some form of access for a limited category of stakeholders relating
to some of the public concerns regarding the control of chemicals.
The apparent high level of inclusiveness described in the preceding
section should not come as a shock. REACH is, after all, the culmination of
an intensive and high-profile nine year review process; its provisions have
been carefully plotted and exhaustively discussed and negotiated in a wide-
206 Veerle Heyvaert
spanning array of public and private settings, in regional, national, European,
and international fora. The European Community is, by now, an experienced
risk regulator, wizened by past controversy and regulatory failure in areas
such as pharmaceuticals control, chemicals, and GMO regulation, and
therefore unlikely to design new regulatory frameworks that overtly and
bluntly sideline major stakeholders and interests. Yet, whether the provisions
in REACH will secure full and effective public participation remains
dishearteningly doubtful, particularly when we take into consideration the
context in which participation takes place.
The Terms of Article 64(2) REACH
A first and smaller point relates to the exact terms of the provisions on public
consultation in the framework of an authorisation application. Article 64(2) of
REACH stipulates that: “The Agency shall make available on its web-site
broad information on uses (…)for which applications have been received and
for reviews of authorisations, with a deadline by which information on
alternative substances or technologies may be submitted by interested
parties”. Now, it is reasonable to expect ECHA to interpret this provision
broadly, if necessary after some prodding by the ECJ, but it nevertheless
remains pertinent that Article 64(2) allows ECHA to construct and, hence,
select, the body of information to be disclosed. More worrying is the explicit
reference to information on alternative substances and technologies. For
reasons of commercial confidentiality alone, this is not the type of
information that will typically be at the disposal of non-industrial
stakeholders. It would probably go too far to argue that Article 64(2) should
be read to exclude submission of information submitted by interested third
parties and relating to other issues than substitution, particularly when read in
conjunction with of the new Community Institutions and Bodies
Regulation, however it may at least foster an informal prioritisation of
The EU Chemicals Policy: Towards Inclusive Governance? 207
information on alternative substances and technologies and, hence, of those
(industrial) stakeholders that possess this type of knowledge.
Structured versus Unstructured Access
A more general observation relates to how the dialogue between public
authority and third parties is structured. An invitation is more welcoming
than an unlocked door. Or, in the context of REACH, explicit solicitation of
opinions, as for instance provided through the forwarding of draft opinions to
applicants, accompanied by a request for comments,70 fosters more a
productive exchange than a simple permission to comment. This, in turn, can
significantly improve the effectiveness of participation.71 Reviewing the
participatory arrangements under REACH, we observe that exchanges with
applicants and with third parties who have information on substitution are
more structured, and therefore arguably more conducive to genuine
deliberation, than those with other interested parties.
The Scope of the REACH Regulation
The degree of inclusiveness of EU regulation tends to be reviewed within the
confines of a specific regulatory framework. However, stakeholder
involvement in regulation is only meaningful if the regulation adequately
covers those activities, practices, and arrangements surrounding which
stakeholders seek to express their interests and public concerns. In this
scenario, if public concern relates to chemicals, or to aspects of their
production, processing, or marketing that are not covered under REACH,
then these concerns cannot find adequate expression within the discursive
space created by regulatory procedures. Reviewing the REACH Regulation,
it is quickly apparent that this regime is much more inclusive in scope than its
predecessor. As mentioned, it covers both old and new substances, and
importantly includes substances in articles, which widens the reach of the
208 Veerle Heyvaert
Regulation to cover most industrial sectors. Whereas formerly information
supply duties for new substances were only triggered upon marketing,
registration is required for production, marketing and use. With the more
inclusive substantive scope of application also comes a wider group of affected
regulatory addressees, as REACH imposes obligations down the supply chain.
However, REACH does have a regulatory blind spot, in that only chemicals
produced or imported in volumes of at least 1 tonne per manufacturer and
per year are subject to registration. This means that about 60,000 substances
listed in the EINECS, many of which produced or traded in small but non-
negligible quantities, are not processed and, hence, not debatable, within the
regulatory system. Also, REACH excludes, inter alia, chemicals used in
agriculture, biocides and cosmetics, which will continue to be governed by
separate regulations.72 The inclusiveness of the EU regime for chemicals
control can therefore only partly be guaranteed by REACH.
Inclusiveness through Integration
A further contextual element to take into account, is that we only obtain a
narrow account of inclusiveness if we restrict our analysis to the development
of formal, or even the formal and informal, channels of communication
between public authorities and stakeholders under the auspices of regulation.
Inclusiveness can however additionally be encouraged through the
introduction of requirements which compel regulatory addressees to identify
and take into account a broadened range interests within assessment and
evaluation processes. Such integrative requirements can be particularly
effective where exclusion is a consequence of oversight rather than deliberate,
and where regulatory addressees may derive potential benefits from interest
integration.
REACH could be said to respond to this version of inclusiveness as it
provides a more integrative approach to the successive steps of risk
The EU Chemicals Policy: Towards Inclusive Governance? 209
identification, risk assessment, and risk management than before. It requires
private actors to draw up guidance notes for safe use and, for substances above
a 10 tonnes threshold, chemicals safety assessments (i.e., risk assessments) and
safety data sheets as a precondition to registration. Thus, contextual factors
pertaining to the use and anticipated or known exposure of a substance
become attached to and can influence the initial risk identification process.
The need to contemplate use and exposure, and to formulate protocols for
safe use, may affect decisions on whether to pursue commercialisation of a
new substance at an earlier stage in the engineering and design process, before
massive costs are sunk in, and may impact on decisions on whether to apply
for registration of older chemicals, thus hopefully fostering a higher level of
responsiveness to health and environmental concerns, and a stronger practice
of self-selection within the chemicals industry, determined by more than the
commercial viability of the contemplated product. Similarly, within the
framework of the authorisation process, Article 55 of REACH insists that all
manufacturers, importers and downstream users must analyse the availability
of alternatives and consider their risks and the technical and economic
feasibility of substitution. This opens up opportunities for a self-imposed,
early, perhaps rather rudimentary comparative risk assessment that can weed
out the more obvious cases where substitutions should be made, thus
obviating the need for a lengthy, vexatious and perhaps ultimately
unsuccessful authorisation procedure.73
We should take care however not to overstate the extent or the
promises of integrated assessment requirements. The overwhelming majority
of substances subject to REACH are marketed in volumes of between one
and ten tonnes per year. Registration of this category of substances does not
require a chemicals safety report (risk assessment). Thus, for an estimated
30,000 substances, the new chemicals control policy will mainly consist of an
information gathering and limited testing exercise. Apart from the
requirement to supply available guidance notes for safe use, very little scope
210 Veerle Heyvaert
exists for risk considerations, whether of a scientific, social or economic
nature, to be integrated into the control process. Koch and Ashford have
voiced a concern that, for most chemicals, the REACH framework will
amount to little else than data collection and box-ticking.74
Moreover, even within the narrowly delineated field of testing data to
be produced in compliance with the registration provisions, questions emerge
as to the effectiveness of the Regulation’s inclusive approach to health and
environmental protection. The process of hazard identification and short term
toxicity testing may generate plausible results for human health assessments,
but it is notoriously feeble when it comes to the identification of
environmental risks. In light of, to name but a few factors, the endless variety
of recipients within ecosystems, the scope for synergic impacts caused by
multiple exposure and opportunities for long term build-up and mutation,
the snap-shot, substance-by-substance approach in laboratory testing makes
for a poor predictor of environmental impacts.75 More robust assessments
generally require a combination of testing, epidemiological studies and
monitoring mechanisms.76 On the latter aspects, REACH is particularly
weak. It is interesting to observe that the critiques on the effectiveness of the
data gathering provisions for environmental risk control are not new; they
have been around since well before the 1998 review.77 However, in contrast
to the criticism on the expediency of the former regulatory framework to
deliver regulatory outcomes, they were not included or addressed in the
reform process.
Finally, where the REACH framework does provide an opportunity
for the inclusion of contextual, socio-economic information within the
earlier stages of identification and assessment, we need to ask ourselves exactly
what can be included. We recall that, within the authorisation procedure, the
applicant may include a socio-economic analysis (SEA), details for which are
mapped out in Annex XVI to the Regulation. When reviewing the elements
that an SEA may cover, it is hard to escape the conclusion that this is
The EU Chemicals Policy: Towards Inclusive Governance? 211
overwhelmingly conceived as an opportunity for the applicant to mitigate any
unfavourable indications in the risk assessment; there is a strong emphasis on
the predicted impact of a refusal on industry, on pricing and consumer
choice, on job security and employment, and on trade and competitiveness.
A reference to consumer and environmental health effects cuts a lonely figure
compared to the plethora of economic impacts to be considered. Moreover,
no mention is made of any information relating to risk perception or risk
communication. In any event, since the SEA will be drawn up by applicants
for authorisation, their incentives to include information that might
strengthen the case for risk control are highly dubious.
The Organisation of Interest Representation
Beyond the challenges posed by the disparities in access for different groups
of stakeholders, and by the substantial limitations of the terms of the
regulatory debate, lies the even more intractable problem of uneven resources
and expertise. Collective action and free rider problems make it a sure bet
that public interest representation will be under-resourced compared to
private interest groups. This is certainly the case for the area of chemicals
control, where one of the major stakeholders, the chemical industry,
constitutes Europe’s third largest industry, employing approximately 1.7
million people, with another 3 million employees in jobs that are directly
dependent on the chemicals sector.78 It is also a rather apprehensive industry,
as in the last seven years growth rates in the chemicals sector, both within
EU-25 and globally, consistently lag behind overall industrial growth rates.79
As indicated before, public interest NGOs did participate vigorously, and
some assert quite successfully,80 in the REACH negotiation process, but it is
undeniable that the chemical industry’s resources and specialised expertise far
outstrip their own, which hampers their ability to participate in decision-
making as effectively as commercial interest representatives. This
212 Veerle Heyvaert
disequilibrium is pushed further by the fact that public interest NGOs tend to
have wide portfolios, and therefore need to be very strategic and selective in
their allocation of resources. Thus, the elevated level of NGO participation in
the “input” phase of REACH does not necessarily imply there will be a
similarly heavy involvement in “throughput” and “output”. A 2007 article in
the ENDS Report on new institutional developments within WWF does
convey the impression that chemicals control is considered a finished project:
“(the) finalisation of the EU’s REACH chemicals regime marks the end of an
era. WWF now wants to focus on climate and resources with its ‘one planet
living’ agenda.(…) Chemicals is one of the areas which has fewest cross-overs
with climate and benefits least from its high profile. WWF is certainly not
alone in dropping its chemicals campaigning – a relatively technical topic that
can be difficult to explain to the public.”81 If this is indeed a marker of a
more general trend, we might wonder whether NGOs have not missed a
trick, since the real impact of substantive risk control requirements hinges to a
considerable extent on their interpretation and application, and it is therefore
crucial to be involved in the interpretation and application process.
Conclusion
The sober tones of the last few paragraphs above notwithstanding, it would
be unfair, and unproductive, to condemn the REACH framework for lack of
inclusiveness. Compared to the old regulatory framework for chemicals
control great improvements have been made in terms of the openness of the
debate leading to the adoption of REACH. Moreover, REACH does
provide a good level of transparency82 -- a prerequisite for any for of
workable participation -- and some opportunity for consultation. Access to
justice remains a weak link, but the 2006 Community Institutions and Bodies
Regulation might create a modest and partial scope for ex-post scrutiny. On
The EU Chemicals Policy: Towards Inclusive Governance? 213
balance, this is a reasonably good scorecard from the point of view of
inclusive governance.
However, a contextual appraisal does indicate that the participatory and
integrative arrangements incorporated in REACH are very brittle, and casts
serous doubts over whether REACH will result in genuinely inclusive risk
management. The organisation of consultation, the scope of the Regulation,
the selection of criteria and reference points to be integrated in assessment
and management processes, and the perennial problem of relative lack of
support and funding for NGO involvement, all conspire to erode, even
trivialise, the inclusive nature of the decision-making framework. This echoes
a message long familiar to those active in anti-discrimination law: the
provision of formal equality is the beginning, not to end of a reform process
towards an inclusive, non-discriminatory society. Drawing the parallel, and
recalling that REACH still falls short of full formal “equality” for all
stakeholders in terms their opportunities for engagement with regulation, the
new EU regime for the control of chemicals could be said to constitute a first
firm step towards the beginning of a reform process leading to inclusive
governance in risk regulation.
214 Veerle Heyvaert
Endnotes 1 Cf. Veerle Heyvaert, “No Data, No Market. The Future of EU Chemicals Control under
the REACH Regulation” Vol. 9 European Law Review (2007), 201. 2 See generally Veerle Heyvaert, Coping With Uncertainty. The Regulation of Chemicals in the
European Union (PhD Dissertation, European University Institute, Florence, Italy, 1999). 3 Dangerous chemicals: chemicals falling into one of the hazard categories set out in
Community law (expanded from 8 initially to 15 now). Identification of a chemical as
dangerous entails imposition of a range of risk management requirements: classification, R-
Phrases and S-phrases, packaging, labelling, enclosing safety data sheets to be passed on to
professional users, worker safety obligations, etc. 4 Council Directive 79/831/EEC amending for the sixth time Directive 67/548/EEC on the
approximation of the laws, regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances [1979] OJ L259/10. 5 Twelve years later, the Existing Substances Regulation would try to correct the information
deficit concerning chemicals for which no notification dossier had been submitted. However,
as will be discussed further below, the information supply obligation in the Regulation were
never properly enforced. 6 Cf. Richard Stewart, “Regulation, Innovation and Administrative Law: A Conceptual
Framework” Vol. 69 California Law Review (1981), 1259-1377. 7 Commission Directive 93/67/EEC of 20 July 1993 laying down the Principles for
Assessment of Risks to Man and the Environment of Substances Notified in accordance with
Council Directive 67/548/EEC [1993] OJ L227/9. 8 C-473/98, Toolex Alpha [2000] ECR I-9741; Heyvaert, “Balancing Trade and Environment
in the European Union: Proportionality Substituted?” Vol. 13 Journal of Environmental Law
(2001), pp. 395-398. 9 [1976] OJ L262/201. 10 [1993] OJ L84/1. 11 See Commission Communication to the Council and the EP – The European Chemicals
Bureau [1993] OJ C1/3. 12 [1998] OJ L131/11. 13 Veerle Heyvaert, “Guidance Without Constraint. Assessing the Impact of the Precautionary
Principle on the European Community’s Chemicals Policy” Vol. 6 Yearbook of European
Environmental Law (2006), 46; and Royal Commission on Environmental Pollution, ‘Twenty
Fourth Report – Chemicals in Products. Safeguarding the Environment and Human Health”
26 June 2003, published on the Internet at: http://www.rcep.org.uk/chemicals.ch00-rep.pdf.
The EU Chemicals Policy: Towards Inclusive Governance? 215
14 Christopher Arup, “Chemical Notification Laws in the OECD Member Countries”, Journal
of World Trade Law (1987), 65. 15 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18
December 2006 concerning the Registration, Evaluation, Authorisation and Registration of
Chemicals (REACH), establishing a European Chemicals Agency, amending Directive
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [2006] OJ L396/1. 16 Provided they are not covered by other, more specific Community legislation, such as
Directive 91/414 (pesticides) and Directive 98/8 (biocides). 17 See also Heyvaert, “No Data, No Market”, n. 1 above, 201-6, and the detailed yearly
overviews by Candido Garcia Molyneux on “Substantive European Community Law –
Chemicals”, Yearbook of European Environmental Law, vols. 5 onwards (2005-2008). 18 REACH Reg. n. 15 above, Title II. 19 See Part II above. 20 See Part II in fine. 21 E.g., detergents. 22 REACH Reg., n. 15 above, Title VI. 23 Ibid., Title VII. 24 Carcinogens, mutagens and substances toxic to reproduction. 25 Persistent, toxic and bioaccumulative substances. 26 Very persistent, very bioaccumulative substances. 27 REACH Reg., n. 15 above, Title VIII. 28 Article 251 EC. 29 N. 13 above. 30 Council Decision 2006/512/EC amending Decision 1999/468/EC laying down the
Procedures for the Exercise of Implementing Powers conferred on the Commission [2006] OJ
L200/11. 31 D. Pocklington, “Comitology Under Greater Scrutiny” Vol. 15 European Environmental Law
Review (2006), No. 11, pp. 306-311. 32 REACH Reg., n. 15 above, Title 10. 33 N. 13 above. 34 See Commission White Paper on European Governance COM(2001)428, 25 July 2001;
Commission Communication - Towards a Reinforced Culture of Consultation and Dialogue:
General Principles and Minimum Standards for Consultation of Interested Parties by the
216 Veerle Heyvaert
Commission COM(2002)704, 11 Dec. 2002; Commission Communication – European
Governance: Better Lawmaking COM(2002)275, 5 June 2002; Commission Communication
– A Strategic Review of Better Regulation in the European Union COM(2006)689, 11 Nov.
2006. See Daniela Obradovic & Jose M. Alonso Vizcaino, “Good Governance Requirements
concerning the Participation of Interest Groups in EU Consultation” Vol. 43 Common Market
Law Review (2006), 1049-85; Deirdre Curtin (ed.), Reflections on Concepts, Institutions and
Substance (Antwerp, Intersentia 2005); and Stijn Smismans (ed.), Civil Society and Legitimate
European Governance (Edward Elgar, 2006). 35 Ibid. 36 M. Florenz, Head of the Committee on the Environment, Public Health and Food Safety,
speaking before the Plenary of the EP discussing the proposed REACH Regulation, 15 Nov.
2005, published on the Internet at:
http://www.europarl.europa.eu/members/public/yourMep/view.do?name=florenz&partNum
ber=1&language=EN&id=1038. 37 [1967] OJ 196/1. 38 [1988] OJ L187/14. 39 [1993] OJ L84/1. 40 [1976] OJ L262/201. See Commission Working Document – Report on the operation of
Directive 67/548/EEC, Directive 88/379/EEC, Regulation (EEC) 793/93, Directive
76/769/EEC SEC(1998)1986, 18 Nov. 1998. 41 Cf. Dieter Pesendorfer, “EU Environmental Policy Under Pressure: Chemicals policy
Change Between Antagonistic Goals?” Vol. 15 Environmental Politics (2006), no. 1, 105-8. 42 COM(2001)88, 27 Feb. 2001. 43 Proposal for a Regulation of the European Parliament and of the Council concerning the
Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a
European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on
Persistent Organic Pollutants} {SEC(2003 1171} COM(2003)644 , 29 Oct. 2003. 44 Pesendorfer, n. 41 above, 111. 45 It should be noted that the authorisation process itself is preceded by another decision-
making sequence, namely decision-making on the inclusion or exclusion of substances in
Annex XIV, which lists substances subject to authorisation. See REACH Reg., n. 15 above,
Arts. 55-59. 46 This stage comprises identification of intrinsic properties and establishment of dose-response
relationships in order to determine either Derived No-Effect Levels (DNELs) or Predicted
No-Effect Concentrations (PNECs).
The EU Chemicals Policy: Towards Inclusive Governance? 217
47 See above. 48 Ibid. 49 But see Part V, Inclusiveness through Integration, below. 50 REACH Reg., n. 15 Above, Art. 62(4)(e). 51 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January
2002 laying down the general principles and requirements of food law, establishing the
European Food Safety Authority and laying down procedures in matters of food safety [2002]
OJ L31/1. 52 REACH Reg. n. 15 above, Art. 64(3). 53 Ibid., Art. 64(5). 54 See http://ec.europa.eu/enterprise/reach/docs/calls/ed_echa_organisation.pdf. 55 ‘Chemicals Agency Finalises Director, Budget’, ENDS Europe Daily 2451, 17 Dec. 2007. See
also http://echa.europa.eu/about_en.html. 56 The Forum will support Member States’ coordination of enforcement activities.
Furthermore, the Commission is assisted by a “High Level Chemical Group”, see “EU High
Level Chemical Group Gives First Report”, ENDS Europe Daily 2454, 20 Dec. 2007. 57 Council Decision 1999/468/EC [1999] OJ L184/23, Art. 5. 58 Such as the adoption of marketing and use restrictions, see Part III above. 59 Dec. 1999/468/EC, as amended, n. 57 above, Art. 5(a). 60 See Gregor Schusterschitz & Sabine Kotz, “The Comitology Reform of 2006. Increasing the
Powers of the European Parliament without Changing the Treaties” Vol. 3 European
Constitutional Law Review (2007), 80. 61 Dec. 1999/468, n. 41 above, Art. 3. 62 ‘Verheugen Charts Green Path for EU Business’ ENDS Europe Daily 2289, 23 Mar. 2007. 63 REACH Reg., n. 15 above, Art. 60(4). 64 Bjorn Hansen & Mark Blainey, “REACH: A Step Change in the Management of
Chemicals” Vol. 15 RECIEL (2006), No. 3, p. 277 65 See, inter alia ,John A. Usher, ‘Direct and Individual Concern – An Effective Remedy or a
Conventional Solution?’ Vol. 28 European Law Review (2003), 575-600; AG Jacobs’ Opinion
in Case C-50/00 Union de Pequenos Agricultores v Council [2002] ECR I-6677; C. Koch,
“”Locus Standi” of private applicants under the EU Constitution: preserving gaps in the
protections of an individual’s right to an effective remedy” Vol. 40 European Law Review
(2005), n. 4, 511-27; and M-P Granger, Towards a Liberalisation of Standing Conditions for
Individuals Seeking Judicial Review of Community Acts: Jégo-Quéré et Cie SA v
218 Veerle Heyvaert
Commission and Unión de Pequeños Agricultores v Council’ 66 Modern Law Review (2003)
124. 66 [2006] OJ L264/13. 67 REACH Reg., n. 15 above, Arts. 118-119. 68 Case T-94/04, European Environmental Bureau (EEB), Pesticides Action Network Europe,
International Union of Food, Agricultural, Hotel, Restaurant, Catering, Tobacco and Allied Worker’s
Associations (IUF), European Federation of Trade Unions in the Food, Agricultural and Tourism sectors
and allied branches (EFFAT), Stichting Natuur en Milieu and Sevenska Naturskyddföreningen v.
Commission [2005] ECR II-4919. See also joined cases T-236/04 and T-241/04, European
Environmental Bureau (EEB) and Stichting Natuur en Milieu v. Commission [2005] ECR II-4945. 69 Cf. Olivier De Schutter, “Europe in Search of its Civil Society” Vol. 8 European Law Journal
(2002), 214. 70 REACH Reg., n. 15 above, Art. 64(5). 71 Obradovic & Alonso Vizcaino, n. 34 above, 1060-61. 72 See Nicolas de Sadeleer, “The Impact of the Registration, Evaluation and Authorization of
Chemicals (REACH) Regulation on the Regulatory Powers of the Nordic Countries” in
Nicolas de Sadeleer, Implementing the Precautionary Principle. Approaches from the Nordic Countries,
EU and USA (London: Earthscan, 2007), p. 334, questioning whether the overlaps and
possible contradictions between the different regimes have been adequately addressed within
REACH. 73 Lars Kock & Nicholas Ashford, “Rethinking the Role of Information in Chemicals Policy:
Implications for TSCA and REACH” Vol 14 Journal of Cleaner Production (2006), p. 40. 74 Ibid., p. 45. 75 See Veerle Heyvaert, Coping With Uncertainty. The Regulation of Chemicals in the European
Union (PhD Dissertation, European University Institute, Florence, Italy, 1999), pp. 126-130. 76 Stuart Dobson, “Why Different Regulatory Decisions When the Scientific Information Base
is Similar – Environmental Risk Assessment” Vol. 17 Regulatory Toxicology and Pharmacology
(1993), pp. 333-345. 77 E.g., Karl-Heinz Ladeur, “Risikowissen und Risikoentscheidung. Kommentar zu Gotthard
Bechmann”, Vol. 74 Kritische Vierteljahresschrift fuer Gesetzgebung und Rechtswissenschaft (1991), p.
249; Vicki Norberg-Bohm, William C. Clark, Bhavik Bakshi, Joanne Berkenkamp, Sherry A.
Bishko, Mark D. Koehler, Jennifer A. Marrs, Chris P. Nielsen & Ambuj Sagar, “International
Comparisons of Environmental Hazards: Development and evaluation of a method for linking
data with the strategic debate on management priorities for risk management,” Working Paper of
the Center for Science & International Affairs, John F. Kennedy School of Government (1992), p. 7.
The EU Chemicals Policy: Towards Inclusive Governance? 219
78 CEFIC, Barometer of Competitiveness 2002, Business impact of New Chemicals Policy,
published on the Internet at: http://www.cefic.org/Files/Publications/Barometer2002.pdf. 79 CEFIC Facts and Figures, December 2006, published in the Internet at:
http://www.cefic.be/factsandfigures/downloads/CHapter%203.pdf. 80 But see Pesendorfer, n. 41 above, 111. 81 “Chemicals NGO forms as climate takes centre stage” ENDS Report, May 2007. Issue 388,
p. 5. 82 REACH Reg., n. 15 above, Arts. 118-119.
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(Antwerp: Intersentia).
Dobson, S. (1993), ‘Why Different Regulatory Decisions When the
Scientific Information Base is Similar – Environmental Risk
Assessment’, Regulatory Toxicology and Pharmacology 17, 333-345.
Garcia Molyneux, C. (2006), ‘Substantive European Community Law –
Chemicals’, Yearbook of European Environmental Law (Oxford: Oxford
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Granger, M. P., ‘Towards a Liberalisation of Standing Conditions for
Individuals Seeking Judicial Review of Community Acts: Jégo-Quéré
et Cie SA v Commission and Unión de Pequeños Agricultores v
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Hansen, B. and M. Blainey (2006), ‘REACH: A Step Change in the
Management of Chemicals’, RECIEL 15: 3, 270-280.
220 Veerle Heyvaert
Heyvaert, V. (1999), Coping With Uncertainty. The Regulation of Chemicals in
the European Union (PhD Dissertation, European University Institute,
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Heyvaert, V. (2001), ‘Balancing Trade and Environment in the European
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395-398.
Heyvaert, V. (2006), ‘Guidance Without Constraint. Assessing the Impact of
the Precautionary Principle on the European Community’s Chemicals
Policy’, Yearbook of European Environmental Law, 27-60.
Heyvaert, V. (2007), ‘No Data, No Market. The Future of EU Chemicals
Control under the REACH Regulation’, European Law Review 9, 201-
206.
Koch, C. (2005), ‘“Locus Standi” of private applicants under the EU
Constitution: preserving gaps in the protections of an individual’s right
to an effective remedy’, European Law Review 40: 4, 511-527.
Kock, L. and N. Ashford (2006), ‘Rethinking the Role of Information in
Chemicals Policy: Implications for TSCA and REACH’, Journal of
Cleaner Production 14, 31-46.
Ladeur, K. H. (1991), ‘Risikowissen und Risikoentscheidung. Kommentar zu
Gotthard Bechmann’, Kritische Vierteljahresschrift fuer Gesetzgebung und
Rechtswissenschaft 74, 241-256.
Norberg-Bohm, V., W. C. Clark, B. Bakshi, J. Berkenkamp, S. A. Bishko,
M. D. Koehler, J. A. Marrs, Ch. P. Nielsen and A. Sagar (1992),
‘International Comparisons of Environmental Hazards: Development
and evaluation of a method for linking data with the strategic debate
on management priorities for risk management’, Working Paper of the
Center for Science & International Affairs, John F. Kennedy School of
Government.
The EU Chemicals Policy: Towards Inclusive Governance? 221
Obradovic, D. and J. M. Alonso Vizcaino (2006), ‘Good Governance
Requirements concerning the Participation of Interest Groups in EU
Consultation’, Common Market Law Review 43, 1049-1085.
Pesendorfer, D. (2006), ‘EU Environmental Policy Under Pressure:
Chemicals policy Change Between Antagonistic Goals?’, Environmental
Politics 15: 1, 105-108.
Pocklington, D. (2006), ‘Comitology Under Greater Scrutiny’, European
Environmental Law Review 15: 11, 306-311.
Royal Commission on Environmental Pollution (2003), ‘Twenty Fourth
Report – Chemicals in Products. Safeguarding the Environment and
Human Health’ 26 June 2003, published on the Internet at:
http://www.rcep.org.uk/chemicals.ch00-rep.pdf.
de Sadeleer, N. (2007), ‘The Impact of the Registration, Evaluation and
Authorization of Chemicals (REACH) Regulation on the Regulatory
Powers of the Nordic Countries’, in de Sadeleer, N., Implementing the
Precautionary Principle. Approaches from the Nordic Countries, EU and USA
(London: Earthscan), 334.
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the Treaties’, European Constitutional Law Review 3, 68-90.
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or a Conventional Solution?’, European Law Review 28, 575-600.
Chapter 7
The Public-private Regulation of Food Safetythrough HACCP: What does it mean for the Governance Capacity of Public and PrivateActors?
Frank Wendler Johann-Wolfgang-Goethe-Universität, Frankfurt am Main
Introduction
Public-private partnerships (PPPs) and different forms of private self-
regulation have gained in prominence as elements of policy-making, not just
within the nation-state but also increasingly within international as well as
European governance, where they are discussed as one of various innovations
to policy-making through the traditional ‘Community method’ (Knill and
Lenschow 2004). The private actors involved in these new forms of
governance as partners of public authorities include not only non-profit
organisations such as environmentalist or humanitarian NGOs, but also to an
increasing degree companies, who are emerging as important direct partners
of both national governments and international organisations in evolving
structures of international governance through voluntary self-regulation.
224 Frank Wendler
Examples for the application of voluntary standards by companies include the
commitment to Corporate Social Responsibility through codes of conduct,
or voluntary codes in the financial markets or the chemicals sector (Haufler
2001), but also the emergence of ‘private authority’ in fields such as global
commerce or the regulation of pharmaceuticals (Ronit and Schneider 1999).
In many other fields, private actors are involved in public policy-making
either through delegated self-regulation, co-regulation or other forms of
public-private partnership. The evolution of these structures of governance
raise a range of questions about the effectiveness and legitimacy of policy-
making beyond the nation-state, but also about more fundamental questions
of sovereignty, as structures and competences of policy-making are re-
calibrated both between the national and international level, and between
public and private actors. Only recently have attempts been made to describe
the patterns of ‘complex sovereignty’ resulting from the simultaneous shifts of
political authority both on the vertical dimension between the nation state,
supranational institutions such as the European Union and the international
level, and on the horizontal level between the public and private sphere
(Grande and Pauly 2006; Schepel 2006).
The regulation of food safety is at the centre of these developments, as
this policy-field has also undergone major changes through both the
internationalisation and privatisation of governance functions. In addition to
the rapid internationalisation of trade flows and the emergence of
corresponding regulatory frameworks through the WTO and its TBT and
SPS agreements, as well as the Europeanisation of food safety regulation in
the recent decade, the policy-field has also witnessed a strong expansion of
different forms of private self-regulation, ranging from publicly-mandated
hygiene and quality management systems to voluntary standards and labelling
schemes. The rise of private actors as direct partners in the regulation of food
safety is also reinforced by the principles of traceability and liability established
The Public-private Regulation of Food Safety through HACCP 225
by the General Food Law, ‘due diligence’ clauses in national legislation, and
the role of companies as applicants in authorisation procedures for genetically
modified food, pesticides, and additives.
Within this range of private contributions to food safety regulation, the
introduction of company-based food safety management systems through
Hazard Analysis and Critical Control Point (HACCP) is a particularly
interesting example for the role of companies as direct partners of public
regulators, and for the (incremental, fragmented) internationalisation of
regulatory standards. Therefore, the development of HACCP changes the
structure of regulation both on the national-supranational and the public-
private dimension: while the introduction of HACCP systems follows on
initiatives to establish an internationally recognised standard of food safety
regulation across regional and national jurisdictions on the level of the Codex
Alimentarius Commission, it allows for a great degree of diversity of food
safety management systems according to regional, national, and local
legislative frameworks. Similarly, with regard to the public-private
dimension, the introduction of HACCP leaves a great degree of leeway for
private actors to implement food safety systems by prescribing key process
characteristics to be implemented in the quality management systems of firms,
although the verification and documentation of these characteristics is made
compulsory through legislative requirements. Therefore, whereas the
introduction of HACCP obviously entails a shift of responsibility to the
private sector, the public element of this regulatory approach can hardly be
said to be being simply driven out by private activities, but is re-constituted
on different levels of regulation such as national jurisdictions, European
directives and regulations, and the general requirements of the Codex
Alimentarius, which are also reflected in the WTO agreements. The
boundaries between public and private authority are thus reconstructed, albeit
on different levels of regulation.
226 Frank Wendler
This view apparently confirms the common assumption in the
literature on private self-regulation that public and private authority do not
evolve in a zero-sum game, but that they are interrelated in dynamic,
synergetic relationships in which the contributions of both sides might
mutually reinforce each other over time (Knill and Lehmkuhl 2002: 99). This
assumption, however, leaves us with the puzzle of how the emergence of
public-private partnerships such as HACCP affects the ability of public and
private actors to define goals and procedures of regulation. Questions in
relation to this puzzle include the following: are the basic objectives of public
policy and the political and legal frameworks through which they should be
delivered still developed by public actors and then delegated to private actors?
Or are we observing private actors – especially firms – assuming the status of
norm entrepreneurs for the definition of common goods themselves,
increasingly replacing the state in this role? What exactly are the synergetic
relations between the public and private sector in the evolution of public-
private partnerships? What role do regional organisations such as the
European Union play in the operationalisation of such elements of private
self-regulation by adopting them as part of their policies?
Against the background of these questions, this Chapter considers the
consequences that the introduction of HACCP systems has had for the
respective governance capacity – defined as the ability to define common
goods and to design political processes and institutional structures for their
delivery – of public and private actors in the field of food safety governance.
Discussing the implications that HACCP has had for the definition of
problem types, the congruence of problems and regulatory structures and
institutional frameworks, this contribution argues that the establishment of
HACCP is not just a modified procedural approach towards given ends, but
that the transition from hierarchical regulation to public-private partnership is
having a transformative effect on how problems, scopes of regulation and
The Public-private Regulation of Food Safety through HACCP 227
institutions are defined, thus fundamentally changing the rationales,
regulatory spaces, and power relations within an important sector of food
safety regulation. Departing from functionalist accounts that explain the
emergence of international cooperation from pressures emanating from
economic and technological developments, the Chapter therefore seeks to
highlight the strategic aspects of public-private partnerships, i.e., those related
to interests, actors, and power relations. Furthermore, it seeks to show that
through the establishment of public-private partnerships, important shifts of
political authority occur not just between, but also within the public and
private sectors, both between different actors involved and between different
levels of regulation – an aspect not sufficiently addressed in existing typologies
of public-private governance.
The Chapter proceeds in three steps. First, the following section sets
out a typology of public-private partnerships and develops the notion of
governance capacity. Secondly, the case study on HACCP is presented,
applying the three main critieria identified in relation to the notion of
governance capacity. Finally, the results of the case study are evaluated and
summarised in the concluding parts of the Chapter.
The Governance Capacity of Public and Private
actors in Public-Private Partnerships
The emergence of public-private partnerships is closely linked to the debate
on governance and the changes with regard to the applied steering-modes
and the actors involved in public policy-making described by this term.
Distinctions of different forms of governance, as compared to classical forms
of government, are therefore to be made both with regard to the actors
involved – implying the cooperation of public and private actors in mixed
policy networks in forms of governance – and with regard to the
228 Frank Wendler
predominant modes of steering – distinguishing new modes of governance
through the application of non-hierarchical modes from the classical
hierarchical intervention of the nation-state (Börzel and Risse 2006: 196).
Still, the cooperation of private actors in the preparation, definition,
application and implementation of public policies can take a variety of forms,
with different degrees of intensity in the involvement of private actors.
Correspondingly, typologies have been developed that try to distinguish
various forms of public-private partnership with regard to the degree of
autonomy given to private and public actors – ranging from the publicly
dominated consultation and co-optation of private actors and forms of co-
regulation to the public adoption of private regulation to forms of PPP
dominated by private actors such as the delegation of public tasks to private
actors (i.e. in standard setting) and private self-regulation in the shadow of
hierarchy and voluntary agreements (Börzel and Risse 2006: 200). These
typologies, however, only provide rather formal criteria for the actual
capacity of both public and private actors to define the objectives and
rationales of action in public-private partnerships.
This question is addressed in more detail by the term ‘governance
capacity’, defined as the ability of both public and private actors to define
objectives of policy-making and to design the political processes and
institutional structures to realise these objectives. It has been argued that the
governance capacity of private and public actors depends on the particular
strategic constellation of a certain field of policy-making, in relation to three
crucial factors: firstly, the problem type present in a given field of policy-
making; secondly, the degree of congruence between the scope of a problem
and regulatory structures; and, finally, the institutional conditions under
which both public and private actors operate (Knill and Lehmkuhl 2002: 86).
The investigation of each of these three criteria give indications about
the ways in which public and private actors cooperate, and how their
The Public-private Regulation of Food Safety through HACCP 229
respective influence plays out in the definition and provision of common
goods. With regard to problem types, these can range from simple
coordination problems, where both an agreement on the provision of a
public good and its regulatory solution exist, to agreement problems, where a
common interest in the common good prevails but disagreements exists with
regard to the solution (a scenario typical for, i.e., questions of technical
standardisation). In this case, distributive conflicts, bargaining processes and
concerns of economic competitiveness are likely to be essential for the
resolution of a problem. While public actors may still have considerable
influence on the resolution of conflicts, private actors are clearly more
prominent in the resolution of these kinds of problem. A third problem type
is formed by defection problems, where incentives are present for actors to
free-ride to achieve economic gains in spite of an overall shared interest in
the provision of a collective good (i.e., environmental protection, or the
avoidance of food scares). It should be expected that both defection and
agreement problems are present in the field of food safety regulation,
depending on the economic and legal incentive structure encountered by
food producers.
Second, the congruence of problem structures and regulatory structures
refers to the question of how far the (geographical, social or technological)
scope of a problem coincides with the institutional structure established to
deal with it, both with regard to the distribution of tasks between the nation-
state and supra- as well as international organisations, and the emergence of
transnational structures of private actors capable of dealing with a problem.
Clearly, this question concerns first of all the adjustment of regulatory systems
within nation-states to international requirements and regulations.
Importantly, a point of particular interest for company-based food safety
management systems is that efforts of public and private actors to adjust
regulatory structures to changing problem scopes emerging from globalisation
230 Frank Wendler
and technological change may evolve at different speeds and in different
directions, suggesting either public or private leadership in the adjustment of
regulatory structures. Apart from the national-supranational dimension, this
co-evolution of problems and structures for their regulation therefore also
entails a public-private dimension. Finally, the institutional aspect involves
classical questions of power and resources in asking about the function of
institutions in structuring strategic choices and interactions between the actors
involved, both on the side of public frameworks of regulation and private
arrangements for the provision of a good.
Large sections of the literature have protrayed the emergence of global
public-private partnerships in a rather functionalistic fashion – as
arrangements to maintain the problem-solving capacity and effectiveness of
public policies against the background of economic interdependencies,
increasing scientific and technical complexity of regulatory tasks, and resulting
deficits of public authorities to fulfill their mandates. Furthermore, most
studies on governance, and public-private regulation more specifically, have
put their focus on issues of problem-solving capacity and effectiveness. This
article seeks to extend this view by showing how the establishment of public-
private partnerships changes also the constellations, interests and power
relations between the actors involved in food safety regulation.
As the following case study on the evolution of HACCP systems will
show, the establishment of public-private partnership can change the strategic
constellation of a policy-field not just by re-distributing tasks and
responsibilities betweeen the public and the private sector for given problems
and to given ends, but also by transforming fundamentally the underlying
definitions of problem types, scopes of regulatory structures, and institutional
frameworks, resulting in fundamental shifts in the rationales of action and
power relations between the involved actors. An important implication is that
shifts in the allocation of responsibility and political power occur not just
The Public-private Regulation of Food Safety through HACCP 231
between the public and private sector, but also within these spheres,
empowering some actors over others and privileging certain courses of action.
This will be explained in more detail in the following section.
Public-Private Partnership in Food Safety
Governance: The Case of HACCP
The system of Hazard Analysis and Critical Control Point (HACCP) is a
preventive approach applied in the food industry to eliminate physical,
chemical and biological hazards, and which is used to identify potential
hazards in the production chain to be controlled and reduced through key
actions, known as Critical Control Points. A key feature of HACCP is
therefore that it is not based on the inspection of finished products but on the
conduct of a risk assessment and the adoption of preventive measures along
the production chain. The concept originally emerged from initiatives by
NASA in the late 1950 to develop a system for the production of safe
nutritional products for astronauts. The first version comparable to HACCP
was developed in 1959 by Pillsbury Company, which started to identify the
critical points in production processes at which microbial hazards were most
likely to occur. New elements introduced by this technique include in
particular the definition of critical limits for different kinds of hazard at the
control points at which hazards were most likely to occur, the validation of
the prescribed steps by scientifically verifiable results, and the establishment of
a full documentation and monitoring system, by which more costly and
ineffective testing procedures for finished products could be avoided. Having
been presented at the American National Conference for Food Protection in
1971 and been applied in the US Food and Drug Administration regulations
in the 1970s, HACCP systems have been integrated into a range of Good
Manufacturing Practices of food companies and formed part of numerous
232 Frank Wendler
food safety legislations since the end of the 1980s. HACCP is neither a
quality management system as such nor a tool for the implementation of
general hygiene requirements (concerning general requirements for technical
equipment and premises, personnnel hygiene, etc), but is integrated in
sanitary operating procedures and can ensure food safety only in conjunction
with good hygiene practices and good manufacturing practices.
Following its adoption by the American FDA, elements of HACCP
have also been integrated into the legislations of many European countries
and made part of regulations at the European level. A first move towards the
establishment of a legal framework for the implementation of HACCP
systems at the European level was made through EU Directive 93/43,
mandating five of the seven principles for parts of the food industry. This
framework was later followed up through the ‘Hygiene Package’ of three
Regulations and one Directive,1 which were adopted in 2004 and entered
into force on 1 January 2006.
The methodology of HACCP is described in the Codex Alimentarius
document ‘Recommended International Code of Practice-General Principles
of Food Hygiene’, which identifies seven elements in the application of
quality management systems.2 These elements are implemented in three main
steps: firstly, a hazard analysis for the production chain is undertaken by
assembling a multidisciplinary team, setting up a description of the product
(composition, strucutre, processing, packaging, storage, consumption,
microbiological and chemical criteria etc), defining the intended use, and
constructing a flow diagram with a description of the manaufacturing process
for the product in question (including information about working premises,
equipment layout, sequence of all process steps, technical parameters of
operations, flow of products, segregation of dirty and clean areas, etc).
Secondly, management critical control points are identified to ensure that
appropriate control measures are effectively designed and implemented;
The Public-private Regulation of Food Safety through HACCP 233
subsequently, critical limits are specified (corresponding to the extreme values
acceptable with regard to product safety in terms of temperature, time, pH,
moisture, additive, salt level, visual appearance or texture, etc), monitoring
procedures are designed at critical control points, and corrective actions
identified. The third main step consists of the verification and documentation
of the HACCP system including audits, the inspection of operations,
confirmation procedures that CCPs are kept under control, validation of
critical limits, and documentation and record keeping of all activities.
In practice, control of the implementation of HACCP systems by
public authorities are mainly limited to checks that a HACCP plan is in place,
that critical control points have been identified, and that systems for the
verification and documentation of a corresponding system have been
established. Another important point is that general hygiene requirements are
separated from the more specific checks and measures based on HACCP, and
that these have been developed according to the established guidelines (BfR
2006). It is important to add that Community legislation does not contain a
requirement for HACCP procedures to be certified under specific quality
assurance schemes. Initiatives to implement HACCP systems through
certification schemes are therefore considered to emanate only from private
initiatives; the only assessment provided for under Community law is an
assessment by the competent authorities in the Member States (Commission
2005). Therefore, enterprises do not need not to resort to external assistance
or expertise to put HACCP systems in place; however, the broad range of
expertise required for the conduct of the first step of hazard identification
often requires such a move, especially for smaller enterprises.
The establishment of a European legal framework for the
implementation of food safety management systems based on HACCP reflects
efforts by DG SANCO of the European Commission to develop a
sufficiently open, flexible approach that recognises different approaches
234 Frank Wendler
towards HACCP and tries to reduce implementation costs, especially for
smaller enterprises. To this end, a series of meetings were held with experts
from the Member States as well as representatives of producers, industry,
commerce and consumers to discuss issues related to the implementation of
HACCP based procedures (Commission 2005). In this context, one of the
main concerns is that in many parts of the food and retail industry, full
HACCP plans cannot be developed because of the size or structure of
businesses, especially with regard to the documentation and verification of
quality management systems. Against this background, European regulations
prescribe the application of food safety management systems based on
HACCP principles without requiring the implementation of a full system in
all cases.
More specifically, Regulation 852/2004 on the hygiene of foodstuffs
requires food business operators to put in place quality management systems
that are based on Hazard Analysis Critical Control Point (HACCP) principles
(Article 5), while recognising that the full application of HACCP is not yet
generally feasible3 and adding that the need for establishing documentation
and records must be commensurate to the nature and the size of the food
business (Article 5 (2) g). The regulation also seeks to strike a balance
between private and public responsibilities, stating that the implementation of
procedures should reinforce food business operators’ responsibility (Article 1)
while recognising that HACCP should not be regarded as a method of self-
regulation and should not replace official controls4 (Rec. 13). Furthermore, it
is stressed that the provision of evidence documenting compliance with
HACCP should take account of the nature and size of the food business
(Article 5). In this context, one of the recitals of the Regulations expressly
states that the application of the HACCP requirements should provide
sufficient flexibility to be applicable in all situations.5
The Public-private Regulation of Food Safety through HACCP 235
The main requirement established for businesses through European
legislation is therefore to establish control systems according to the key
HACCP principles, while recommending the implementation of full
HACCP systems to comply with the principles of consumer protection and
producer liability enshrined in the GFL, and due diligence clauses in many
national legislations (such as the British Food Safety Act). Many enterprises
integrate HACCP in quality management systems to demonstrate
compliance. Furthermore, it is recognised that in food businesses in which
there is no preparation, manufacturing or processing of food, all hazards can
be controlled through the implementation of the prerequisite requirements
(for example in the case of marquees, market stalls and mobile sales vehicles,
establishments mainly serving beverages (bars, coffee shops etc.), small retail
shops (such as grocery shops), and the transport and storage of pre-packed
food). In these cases it can be considered that the first step of the HACCP
procedure (hazard analysis) has been performed and that there is no further
need to develop and implement the other HACCP principles.
The attempts made by the European Commission to exempt smaller
businesses from HACCP requirements has also given rise to controversial
debates about the correct balance between flexibility and food safety in recent
months. In this context, the European Commission has developed a draft
proposal to amend Article 5 of Regulation 852/2004 under its Better
Regulation initiative and exclude food businesses with fewer than ten
employees from being required to put in place food safety management
procedures based on HACCP.6 DG SANCO argues that its proposal would
mean that small food businesses would only be excluded from the
requirement of establishing a document for identifying and controlling
hazards in food and would have to meet all other requirements. This proposal
has met with strong resistance from some national food safety authorities,
whose representatives argue that the application of hazard identification and
236 Frank Wendler
control techniques should not depend on the size of an undertaking but on
the risk in a given production or preparation process. It has also been argued
that it is precisely small enterprises that are often the source of food hazards
such as salmonella.7
These observations indicate that the recent adoption of European
regulations through the ‘hygiene package’ has not led to a centralisation of
competences for food safety management systems at the European level.
Instead, the legal framework for the establishment of company self-regulation
through HACCP systems presents itself as a multi-level structure, involving
both national and European laws as well as internationally defined principles
and requirements.
How is the governance capacity of public and private actors affected by
the emergence of this complex framework of rules and requirements? This
question will be discussed in the following paragraphs, according to the three
criteria of investigation presented above.
Problem Type
At first sight, the introduction of quality management systems in the food
sector may appear as a defection problem: producers may have the incentive
to free-ride on the introduction of food safety standards across industries,
taking advantage of the contributions of other market participants and the
general improvement of quality standards while compromising on their own
standards to avoid costs and therefore improve their market position. This
assumption, however, stands in contrast with the observation within several
empirical studies that, in many cases, food companies introduce quality
management systems that are more stringent and that go beyond the
minimum standards prescribed by public regulation (Fulponi 2006: 4).
Surprisingly, retailers frequently set their quality standards above the
minimum standards even in cases where these are not communicated to
The Public-private Regulation of Food Safety through HACCP 237
consumers (i.e., by premium labels) and, therefore, used for a differentiation
of products in response to consumer demands for higher quality (Fulponi
2006: 4).
This observation raises a question about the incentives of firms to
comply with voluntary quality standards. Generally, a consideration shared by
all producers and retailers in the food market is the objective to keep markets
stable both generally, in order to avoid disruptions through food safety crises,
and to achieve and maintain consumer trust in their own products. In this
sense, reputation is apparently a very strong incentive for retailers to
implement quality management systems that go beyond minimum standards
(Fulponi 2006: 6). Furthermore, European legislation on hygiene
requirements has shifted responsibility to producers and retailers through its
traceability and liability requirements and has therefore greatly increased the
pressure on enterprises to implement high quality standards (ibid.). Beyond
these general considerations, however, the introduction of private voluntary
standards offers incentives to producers to implement food safety
management systems in two quite different forms of strategy.
First, producers and retailers may agree to implement private standards
in place of missing or inadequate public standards with the aim of increasing
the safety of products generally and to maintain the confidence of consumers.
In particular, retailers may be interested in increasing the quality of products
supplied by farmers in general, thus making sure that products meet certain
safety standards and to avoid food safety crises that would disrupt the
functioning of markets for all retailers and producers. In this sense, the main
incentive for the implementation of private food safety standards is related to
a ‘public good’ or providing safe foods to all consumers and to raise food
safety standards in general. A positive side-effect of this strategy for private
actors may be that by implementing tough standards they can convince
regulators to ‘leave them alone’ and refrain from direct regulatory
238 Frank Wendler
intervention (Codron et al. 2005: 272; Henson et al. 2005: 245; Bernauer and
Caduff 2004: 16).
In contrast to this first strategy, however, the introduction of privately
managed food safety systems offers great incentives for firms to establish
systems that meet public minimum quality standards, but that go beyond
them by offering specific premium products that target specific consumers
segments (i.e., those interested primarily not in the price and quantity, but
quality and safety of a product). Such premium product lines are frequently
(although not exclusively) linked to the branding of products, which can
therefore be distinguished from general product lines by the consumer.
Prominent examples of such premium product lines include Loblaw`s
President`s Choice, Tesco`s Nature`s Choice and Carrefour`s Fillière Qualité
(Fulponi 2006: 7). Branded products can therefore be made to communicate
quality and process characteristics through private standards that would not be
visible from requirements set through public regulation – an important
incentive for retailers to develop these standards and replace public by private
regulation. In this sense, private standards are used as a tool for product
differentiation, which can be considered a ‘private good’ produced through a
market mechanism in which consumers agree to pay higher prices for
products that are superior in appearance, quality, taste, smell, and other
attributes. It is noteworthy, furthermore, that quality labels are often not
confined to attributes of a product, but also relate to social and ethical aspects
of production methods (fair trade, minimum social standards such as ILO
conventions, etc), as well as ecological and animal welfare aspects (Hatanaka
et al. 2005: 356; Fulponi 2006: 8). Although not required by HACCP
principles, the establishment of branding schemes and quality labels is closely
linked to the establishment of company-managed food safety management
schemes: these are used strategically by companies to target specific consumer
segments or gain access to specific markets (Hatanaka et al. 2005: 356).
The Public-private Regulation of Food Safety through HACCP 239
The rationale for retailers with regard to the objective of food safety,
however, is more exclusive than in the first example, as branding is used to
distinguish certain products from others on the market and therefore to shield
them from food safety crises on the market. The achievement of food safety
and consumer trust is therefore linked to economic incentives and privatised
through the instrument of consumer choice. It is also clear that firms trading
primarily with brand products appear more willing to implement HACCP
systems (Bernauer 2004: 14; Codron et al. 2005: 272). As stated above, the
differentiation of food products through private standards appears intrinsically
linked to the transition from the ‘materialist’, price- and quantity-based
competition of retailers to a more ‘post-materialist’ form of competition based
on the quality, origin, as well as the production and trading methods used for
the production of foods (Busch and Bain 2004: 324). In this context, retailers
in particular are incentivised to use the application of food safety standards
strategically to insulate themselves from food safety crises, gain consumer
trust, to differentiate products, and to gain access to specific segments of the
market (Hatanaka et al. 2005: 356).
Against this background, many of the difficulties in relation to the
introduction of quality management systems based on HACCP present
themselves as agreement problems, characterised by a common interest in the
provision of a common good and disagreement about the regulatory solution.
This is demonstrated by the fact that the introduction of HACCP
standards in Europe has not led to the introduction of a single process
standard that is recognised across Member countries. Instead, various
certification systems based on the principles of HACCP have emerged mainly
through initiatives of major retailers and which are not easily compatible with
each other. One of the first of these standards was the British Retail
Consortium (BRC) Food Technical Standard,8 developed in 1996 by
companies including Safeway, Tesco, Sainsbury, Somerfield, Boots and
240 Frank Wendler
Waitrose as a list of criteria for auditors for suppliers and food companies.
One of the main aims of this standard was to avoid a situation in which each
of the major retailers had to conduct audits with its suppliers individually.
The introduction of this standard did not, however, prevent single retailers
from establishing additional requirements for their suppliers and mandating
single specific auditing institutes or even its own company auditors to apply
these standards. This led to the situation that producers and food companies
frequently had to undergo a variety of auditing procedures required by
different retailers, in spite of having undergone the audit for the generally
applied food safety standard. Obviously, the multiplication of such audits
creates a major burden especially for smaller companies that can face up to 15
audits in order to meet the standards of all the retailers they supply.
Parallel to this development, several quality standards based on HACCP
principles were developed through the International Food Standard (IFS),9
according to which management systems were introduced mainly in
Germany by major retailers such as GLOBUS, Metro, EDEKA, REWE and
tegut, and through a HACCP system developed in the Netherlands (‘Dutch
HACCP’).10 Recognised as a certified standard by the German Federation of
Retailer Associations (BDH) in 2002, the IFS is now applied throughout the
German food retail industry. Within an international comparison, these
European systems for the implementation of HACCP differ significantly to
the main American standard FPA-SAFE,11 developed also by food producers
in cooperation with retailers.
It appears as a result of these various developments described above,
therefore that although HACCP is now broadly accepted as the main process
standard for food throughout production and supply in Europe, a variety of
certification schemes exist, thus creating obstacles for trade and especially
those suppliers that produce for various retailers. Furthermore, the
The Public-private Regulation of Food Safety through HACCP 241
transparency and effectiveness of food safety management may be impeded by
the coexistence of a variety of process standards based on HACCP.
Against the background of this variety of standards, various initiatives
have been undertaken by private enterprises to establish a single process
standard based on HACCP, which could be applied for all certification
systems. The first of these attempts was the development of the Global Food
Safety Initiative (GFSI),12 carried forward by multinational retailers organised
in the Food Business Forum CIES.13 The success of the GFSI initiative,
however, has apparently been only limited, mainly because of the reluctance
of the major retailers to accept the common standard.
Another attempt at the harmonisation of food safety management
systems is the establishment of the ISO 2200014 standard by the International
Organization for Standardization. Developed by a working group with
representatives of 14 countries from all continents, the Codex Alimentarius,
the above-mentioned GFSI and representatives of the European food industry
organisation CIAA, it is established with the objective of achieving
international harmonisation in the field of food safety standards. The new
ISO 22000 standard can be characterised as a combination of existing quality
standards enshrined in the older ISO 9001 standard, and a system for the
implementation of HACCP principles. An important feature of the new ISO
standard is that, in contrast to existing systems such as BRC and IFS, it does
not include a list of requirements for Good Manufacturing Practice. Instead,
ISO 22000 puts the onus on companies to define the best practice that is
most relevant to it, thus integrating the definition of best practice into the
system of private self-regulation. Being less prescriptive than established
standards such as the BRC, the ISO standard therefore puts a greater
responsibility on producers to look at their internal system of quality
management and to decide how standards can be best achieved. Compared to
existing management systems, the introduction of ISO standards would
242 Frank Wendler
therefore require some changes in the mindset of producers. It remains to be
seen, therefore, in how far the new ISO standard will be accepted as a
harmonised standard for all stages in the production chain.
The transition to an internationally harmonised food safety
management is, however, unlikely to be easy due to the incentive structure of
companies, who use standards not just to avoid food safety problems, but also
strategically to address specific markets segments and consumer groups, and to
be able to isolate themselves from general developments in the food market.
This emergence of ‘private authority’ also has consequences for the scope and
structure of food safety regimes globally, as will be explained in more detail in
the next section.
Congruence of Problem Scope and Regulatory Structures
A second criterion for assessing the respective governance capacity of public
and private actors is the degree of congruence between the scope of a given
problem and the regulatory structures that have been established to deal with
it. Given the simultaneous establishment of HACCP principles on the global
and European level and the proliferation of quality management systems to
implement these principles, it appears that the relationship between problems
and regulatory solutions develop on two different levels for the public and
private sectors: whereas the development of public regulatory frameworks for
the implementation of HACCP is mainly defined in terms of territorially
defined units such as national legislations and supranational legal frameworks
defined by the European Union, private actors define production standards
primarily along production and supply chains, independently of territorial
boundaries.
The regulation of the agri-food industry is therefore no longer defined
exclusively within national borders but by areas of activity and supply chains
defined mainly by large multinational supermarkets. A result of this
The Public-private Regulation of Food Safety through HACCP 243
development is the emergence of interaction effects between different
national legislations and regional standards of public regulation (such as
European, African, Latin American levels of standards), as production and
supply chains of multinational companies cut across these regulatory areas.
Apparently, these interdependencies do not lead to a ‘race to the bottom’ of
food safety standards, but have the effect that supermarket chains adapt to the
most demanding standards of the markets they serve in order to reduce
coordination and supply costs, thus implementing much more stringent
standards than required by public legislation in some of their markets and
supplier countries (Henson et al. 2005: 247). The stronger reliance on private
standards in combination with the tendencies of trade globalisation and the
concentration of markets may therefore have the effect of driving up
standards for producers and suppliers, especially in countries with comparably
low public standards. As a consequence, private standards developed by
enterprises in strongly regulated markets, such as the Eurepgap system, are
‘exported’ to suppliers in developing countries who need to adapt to such
quality management systems in order to remain in the supply chain for large
retailers.
The introduction of private food safety management systems may
therefore have effects far beyond the regulatory area in which these were
initially developed and required by public regulation: although standards may
remain voluntary, they may quickly become essential for suppliers to maintain
their reputation and be accepted by the retail companies as trade partners,
thus making the most established voluntary standards de facto mandatory for
producers if they want to remain in the supply chain and thus on the market
(Hatanaka et al. 2005: 360). It is obvious that very large corporations with a
strong degree of buying power have the prerequisites to impose their
standards on suppliers, in addition to the fact that these production chains
often offer higher prices or other assistance to producers (Henson et al. 2005:
244 Frank Wendler
247). Producers from developing countries, on the other hand, may benefit
from their inclusion in quality management systems through private standards
by being recognised as reliable producers and therefore gaining wider market
access.
These developments indicate, therefore, that the definition and
implementation of food safety standards is not solely defined by national
legislation or regional frameworks of legislation defined by the European
Union, but increasingly set through private regimes of companies and their
supply chains that extend across territorial borders. It is clear, furthermore,
that this tendency is reinforced through the process of concentration on the
food markets, especially with regard to very large supermarket chains that
operate globally and have an increasing presence in the markets of developing
countries as well (cp. Bernauer and Caduff 2004: 15ff.).
Institutional Context
The introduction of private self-regulation mechanisms through HACCP is
embedded in a radical change of the institutional framework in which food
safety regulation is conducted. Above all, this is primarily a development of
internationalisation and Europeanisation: whereas HACCP is a system that
was first introduced by the international Codex Alimentarius Commission, its
application is now prescribed and structured by European laws and
regulations; furthermore, the expansion of multinational companies and the
corresponding rise of global private standards is strongly related to the
opening of markets reinforced by the World Trade Organisation and the SPS
and TBT agreements (Busch and Bain 2004: 325ff.). One of the main
consequences for the public regulation of food safety, however, is the vertical
fragmentation of authority across the national, regional and international
level: whereas the general principles and main steps of HACCP systems have
been defined primarily at the international level of the Codex Alimentarius
The Public-private Regulation of Food Safety through HACCP 245
Commission, it is the regional European level of institutions that has become
particularly decisive in the definition of how these principles are integrated
into the specific system of risk assessment and risk management as defined by
the General Food Law that binds Member States. Given the limited
competences of the European Food and Veterinary Office and the leeway
which the European regulations give in the application of HACCP systems, it
is, however, clear that the key role in the oversight and control of the
implementation of HACCP remains at the national, or even sub-national
level (as in Germany, where the inspection and control of food enterprises is
largely left to the Länder authorities; cp. Dressel et al. 2006).
An important consequence is that it has become difficult to assess the
governance capacity of public actors on one level in separation from each
other, but that different aspects of this capacity are now dispersed on different
levels: whereas the ability to define principles of food safety management
through private actors is now shared between the international (i.e. Codex
Alimentarius) and European level, the capacity of designing the procedures
and conditions for their delivery are still mainly defined by national
legislation, leaving much room for regional and local authorities to spell out,
monitor, and enforce HACCP standards, as well as cross-national diversity of
regulations. The shift of responsibilities to private actors affected through
HACCP is therefore accompanied by the dispersion of regulatory authority
of public institutions in a multi-level system of governance (Bernauer and
Caduff 2004: 17f.). Above all, this fragmentation may raise problems in terms
of transparency; it is, however, also an example for the emergence of a
governance system characterised by a ‘complex sovereignty’ (Grande and
Pauly 2006: 15ff.), in which no regulatory level is independent of the actions
of related actors and institutions on different levels.
The introduction of HACCP, furthermore, has also changed the
institutional arrangements in which companies of the food sector operate.
246 Frank Wendler
Key among these changes is the rise in importance of third-party certifiers
(TPCs) and the (both public, semi-public and private) accreditation bodies
mechanisms through which these certifiers are authorised to verify the
compliance of producers and suppliers with HACCP systems (Hatanaka et al.
2005: 357ff.). Third party certifiers have gained in importance because they
are recognised as independent, thus replacing in-house experts for the
certification of quality management procedures. The introduction of third-
party certification, however, has important repercussions for the relationship
between producers, suppliers and retailers: supermarkets are particularly likely
to benefit, as they are able to control the quality standards of producers and
suppliers without needing to monitor them directly; furthermore,
responsibility is mainly shifted up the production chain to the producers, as is
liability should a problem occur (Hatanaka 2005: 365).
The rise of third-party certification also has the effect of shifting costs
to producers, who need to apply to one of the accredited bodies for
certification and subsequently have to undergo pre-assessments,
documentation reviews and field audits by the certifier. In most cases, the
costs for these certifying procedures are met by the supplier (Hatanaka et al.
2005: 357). For smaller producers in particular, these costs can be prohibitive,
as producers are asked to pay a daily fee of several hundred dollars for experts
from certifying bodies to come in and inspect local operations, whereas these
inspections can be very burdensome for producers in terms of
documentation, hygiene, cleaning and premises requirements. Producers,
therefore, face the choice of facing these costs or else losing their chance of
being accepted as a supplier if they do not take the audit; obviously, this
dilemma applies particularly to smaller producers in developing countries
where no competent certification bodies exist, and which require external
experts from Europe or the United States to come in and undertake audits15
(Hatanaka et al. 2005: 361).
The Public-private Regulation of Food Safety through HACCP 247
The Strategic Constellation of Public and Private
Actors in HACCP: the Transformative Potential of
Public-private Partnerships
From what has been said above, it has become clear that the introduction of
HACCP systems has fundamental consequences not just for the procedural
forms of policy-making, but also for the rationales, actor constellations and
power relations within the field of food safety regulation. In this context,
several authors assume that the introduction of private food safety and quality
management systems on the basis of HACCP mainly privilege retailers,
especially multinational supermarket chains, and are conducive to the
development of market concentration, while imposing heavy burdens for
smaller producers particularly in developing countries (Busch and Bain 2004,
Bernauer and Caduff 2004). Furthermore, the introduction of such systems
are seen to lead to a fragmentation of political authority of public institutions
across the national, European and international level and therefore question
principles of transparency and accountability; instead of the traditional form
of hierarchical regulation through law in a closed nation-state, what can be
seen to emerge is the establishment of globalised private regimes of food
safety regulation across territorial boundaries, which are steered mainly by
large multinational food companies with significant power over the
distribution of crucial resources such as market access, consumer confidence
and reputation.
Several recent developments can be seen to question this perspective.
Firstly, recent efforts to establish a globally harmonised standard for the
certification of HACCP through the ISO 22000 standard could lead to a
development in which the currently fragmented structure of private food
safety management systems is re-integrated or at least re-directed towards a
single standard, thus increasing transparency, lowering certification costs for
producers and allowing for broader market access of companies certified
248 Frank Wendler
against this standard. Secondly, recent developments in the legislative
framework of the European Union indicate that in the context of ‘Better
Regulation’ initiatives, greater tolerance margins could be given to small and
medium enterprises, meaning that larger firms could face more serious costs
in the implementation of HACCP systems than smaller ones who are not
obliged to fulfill the full circle of requirements. Furthermore, given the
increasing importance of NGOs campaigning for the inclusion of social,
ethical and animal welfare standards into food safety management systems, the
pressure could be expected to be higher on big companies such as
McDonald`s or Starbucks, as these are more easily named and shamed than
smaller enterprises. In the same vein, risks and losses in terms of reputation
can also be assumed to be greater for big companies with regard to the
principles of traceability and liability, which are now central principles of the
European framework of food safety regulation. Finally, the still rather low
degree of implementation of HACCP systems may put a limit on the
developments described above, especially with regard to smaller producers.
It would therefore be too easy to state that only some specific actors –
i.e., say, multinational companies in the retailer sector – gain from the
introduction of public-private partnerships whereas others lose out. A more
fundamental observation is, however, that many of the basic structures and
conditions of food safety regulation are changed by the introduction of
HACCP, affecting the way problems are defined, competition is organised
and rules of the game are set. The introduction of elements of private self-
regulation into the management of food safety is therefore not just a shift
towards more private responsibilities within the same basic framework of
problems, regulatory structures and institutions, but transforms these
underlying conditions. As argued above, such transformative effects can be
observed at all three levels of analysis in relation to the governance capacity of
public and private actors:
The Public-private Regulation of Food Safety through HACCP 249
Firstly, with regard to the given problem types, the introduction of
HACCP signifies the transition from command-and-control systems with
typical defection problems to increased responsibility of the private sector on
the basis of quality-based competition, leading to a differentiation of
standards, the introduction of branding and premium labelling schemes and
the emergence of agreement problems between different certification systems.
Whereas the governance capacity of public actors with regard to these types
of problem appears limited, economic incentives for companies to maintain
exclusive quality management standards and distributive conflicts on the costs
and benefits of agreeing on a harmonised standards can be expected to gain in
importance. Strongly related to this problem is the increased politicisation of
food safety issues and the growing public perception of food scares, which
can be seen to reinforce the tendency towards a quality-based competition.
Secondly, with regard to the congruence of problem structures and regulatory
structures, we observe a discrepancy between public regulatory frameworks,
which are defined mainly along territorial lines, and private quality
management systems, which are organised along production and supply
chains. While both structures of regulation are not congruent, interaction
effects can be observed through the adjustment of standards within supply
chains to the toughest market they serve, whereas the definition of standards
through public regulation is differentiated in relation to size of enterprises.
The effect may be that a small enterprise in Europe has to face lower food
safety requirements than a fruit plant in Africa serving a European business.
The level of regulation is therefore no longer entirely set by territorial
boundaries, but increasingly depends on the position of an enterprise within
the market.
Thirdly, with regard to the institutional framework, the development of
HACCP takes place in the context of a dispersion and fragmentation of
regulatory functions across various levels. Simutaneously, the institutional
250 Frank Wendler
arrangements within the private sector witness a shift of responsibilities
towards producers and suppliers and the rise in importance of third-party
certifiers, whereas retailers appear to benefit most from the introduction of
HACCP in terms of costs and responsibilities. Fundamental changes have
therefore taken place not just between the public and private sector, but
within these sectors: whereas the competences of public actors generally may
be strong in terms of defining objectives and procedures of food safety
regulation and sanctioning non-compliance, the actual capacity to act of
regulators on each of these levels is limited by the dispersion of tasks across
the national, European and international levels. Whereas the general
principles and tasks of HACCP are now defined almost exclusively at the
international level, it is mainly the national and local level that remains
responsible for the application, implementation and supervision of these
systems. In between these levels, the European Union can be seen to act in
an intermediate function of defining in how far national legislation should
converge and how much leeway should be given in the application of
company self-regulation (i.e., in the case of smaller enterprises). The
European Union also appears to play a central role in balancing the objective
of food safety with negative externalities in other areas, as expressed in the
tension between the ‘Better Regulation’ objectives of providing generous
exemptions to smaller undertakings, and the principle of the highest standard
of consumer protection.
Conclusions
Against the background of a literature on private self-regulation that is
primarily concerned with procedural and structural concerns, this Chapter has
tried to highlight the strategic aspects (i.e., those concerned with conflict and
power) and the transformative effect of new forms of public-private
governance such as HACCP on the interests, actors and institutional
The Public-private Regulation of Food Safety through HACCP 251
frameworks of policy-making. Public-private partnership, in this context, is
not simply a different, and potentially more effective, means to address given
problems through changed procedures. It changes the way problems and the
scope of regulation are defined, changes the allocation of political authority in
institutional frameworks, and has both empowering and excluding effects on
both economic and political actors. Such questions of power and interest,
however, deserve further attention in research of governance through private
actors, which has focused mainly on the issues of problem-solving
effectiveness.
Another lesson to be learnt from this case-study is to provide insights
into how the evolution of public-private partnerships causes shifts of
responsibility and political power not just between the public and private
sphere, but also within these sectors, especially between different actors in a
production chain, and between the different levels of regulation across the
national, European, and international levels. To integrate these insights into
existing typologies of public-private cooperation, which treat the public and
private spheres as relatively closed and unitary, is an issue that research on
governance through private self-regulation has only just started to address.
Notes
1 These include: Regulation (EC) 852/2004 of the European Parliament and of the Council of
29 April 2004 on the hygiene of foodstuffs, OJ L 139; Regulation (EC) 853/2004 of the
European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules
for food of animal origin, OJ L 139; Regulation (EC) 854/2004 of the European Parliament
and of the Council of 29 April 2004 laying down specific rules for the organisation of official
252 Frank Wendler
controls on products of animal origin intended for human consumption, OJ L 139; and
Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004
repealing certain Directives concerning food hygiene and health conditions for the production
and placing on the market of certain products of animal origin intended for human
consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council
Decision 95/408/EC, OJ L 157. 2 These steps include: (1) identifying any hazards that must be prevented, eliminated or
reduced to acceptable levels (hazard analysis); (2) identifying the critical control points at the
step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to
acceptable levels; (3) establishing critical limits at critical control points that separate
acceptability from unacceptability for the prevention, elimination or reduction of identified
hazards; (4) establishing and implementing effective monitoring procedures at critical control
points; (5) establishing corrective actions when monitoring indicates that a critical control
point is not under control; (6) establishing procedures, which shall be carried out regularly, to
verify that the measures outlined in paragraphs 1 to 5 are working effectively; (7) establishing
documents and records commensurate with the nature and size of the food business to
demonstrate the effective application of the measures outlined in paragraphs 1 to 6. 3 Regulation 852/2004/EC, supra note 1, Recital 11. 4 Regulation 852/2004/EC, supra note 1, Recital 13. 5 Regulation 852/2004/EC, supra note 1, Recital 15 states: ‘The HACCP requirements should
take account of the principles contained in the Codex Alimentarius. They should provide
sufficient flexibility in all situations, including in small businesses. In particular, it is necessary to
recognise that, in certain food businesses, it is not possible to identify critical control points and
that, in some cases, good hygienic practices can replace the monitoring of critical points.
Similarly, the requirement of establishing ‘critical limits’ does not imply that it is necessary to
fix a numerical limit in every case. In addition, the requirement of retaining documents needs to
be flexible in order to avoid undue burdens for very small businesses’ (emphasis added). 6 Cp. EU Food Law Weekly, 4 May 2007. 7 Cp. EU Food Law Weekly, 4 May 2007. 8 For further information, see: <www.brc.org.uk>. 9 For further information, see: <www.food-care.info>. 10 For further information, see: <www.foodsafetymanagement.info>. 11 For further information, see: <www.fpa-safe.org>.
The Public-private Regulation of Food Safety through HACCP 253
12 For further information, see:
<www.ciesnet.com/2-wwedo/2.2-programmes/2.2.foodsafety.gfsi.asp>. 13 For further information, see: <www.ciesnet.com>. 14 See:
<www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=35466&ICS1=67
&ICS2=20&ICS3>. 15 As a drastic example, Hatanaka et al. note that in Ghana only one individual is qualified, but
is not accredited to certify according to EUREP standards, thus requiring certifyers from
Europe to come in (Hatanaka et al. 2005: 362).
References
Bernauer, Th. and L. Caduff (2004), ‘European Food Safety: Multilevel
Governance, Re-Nationalization, or Centralization?’ CIS Working
Paper No 3, 2004, Center for Comparative and International Studies,
ETH Zürich.
Börzel, T. and Th. Risse (2006), ‘Public-Private Partnerships: Effective and
Legitimate Tools of Transnational Governance?’, in Grande, E. and L.
Pauly (eds.), Complex Sovereignty. Reconstituting Political Authority in the
Twenty-First Century (Toronto: University of Toronto Press), 195-216.
Bundesinstitut für Risikobewertung BfR (German Federal Institute for Risk
Assessment) (2005), ‘Fragen und Antworten zum Hazard Analysis and
Critical Control Point (HACCP)-Konzept, brochure on basic
questions of HACCP (in German)’,
<http://www.bfr.bund.de/cm/234/fragen_und_antworten_zum_haza
rd_analysis_and_critical_control_point__haccp__konzept.pdf>.
Busch, L. and C. Bain (2004), ‘New! Improved? The Transformation of the
Global Agrifood System’, Rural Sociology 69: 3, 321-346.
254 Frank Wendler
Codron, J.-M., E. Giraud-Héraud and L.-G. Soler (2005), ‘Minimum quality
standards, premium private labels, and European meat and fresh
produce retailing’, Food Policy 30, 270-283.
Commission of the European Communities (2005), Guidance Document on the
Implementation of procedures based on the HACCP principles, and facilitation
of the implementation of the HACCP principles in certain food businesses, DG
SANCO, Brussels, 16 November 2005.
Dressel, K. et al. (2006), ‘Food Safety Regulation in Germany’, in Vos, E.
and F. Wendler (eds), Food Safety Regulation in Europe. A Comparative
Institutional Analysis (Antwerp: Intersentia), 287-330.
Fulponi, L. (2006), ‘Private voluntary standards in the food system: The
perspective of major food retailers in OECD countries’, Food Policy 31,
1-13.
Global Food Safety Initiative (GFSI) (2004), GFSI Guidance Document, 4th
Edition, online:
<http://www.ciesnet.com/pfiles/programmes/foodsafety/GFSI_Guida
nce_Document_4th_edition.pdf>.
Grande, E. and L. Pauly (eds) (2006), Complex Sovereignty (Toronto:
University of Toronto Press).
Haufler, V. (2001), A Public Role for the Private Sector (Washington DC:
Carnegie Endowment).
Hatanaka, M., C. Bain and L. Busch (2005), ‘Third-party certification in the
global agrifood system’, Food Policy 30, 354-369.
Henson, S. and Th. Reardon (2005), ‘Private agri-food standards:
implications for food policy and the agri-food system’, Food Policy 30,
241-253.
Knill, Ch. and D. Lehmkuhl (2002), ‘Conceptualizing the Role of Public and
Private Actors’, in Héritier, A. (ed.), Common Goods. Reinventing
The Public-private Regulation of Food Safety through HACCP 255
European and International Governance (Lanham: Rowman and
Littlefield), 85-104.
Knill, Chr. and D. Lehmkuhl (2002a), ‘Private Actors and the State:
Internationalization and Changing Patterns of Governance’, Governance
15: 1, 41-63.
Knill, Chr. and A. Lenschow (2004), ‘Modes of regulation in the governance
of the European Union: towards a comprehensive evaluation’, in
Jordana, J. and D. Levi-Faur (eds), The politics of regulation. Institutions
and regulatory reforms for the age of governance (Cheltenham: Elgar), 218-
244.
Pauly, L. and E. Grande (2005), ‘Reconstituting Political Authority:
Sovereignty, Effectiveness, and Legitimacy in a Transnational Order’,
in Grande, E. and L. Pauly (eds), Complex Sovereignty. Reconstituting
Political Authority in the Twenty-First Contury (Toronto: University of
Toronto Press), 3-21.
Porter, T. and K. Ronit (2006), ‘Self-regulation as policy process: The
multiple and criss-crossing stages of private rule-making’, Policy Sciences
39, 41-72.
Ronit, K. and V. Schneider (1999), ‘Global Governance through Private
Organizations’, Governance 12: 3, 243-266.
Schepel, H. (2005), The Constitution of Private Governance. Product Standards in
the Regulation of Integrating Markets (Oxford: Hart Publishing).
Sparling, D., J. Lee and W. Howard (2001), ‘Murgo Farms Inc.: HACCP,
ISO 9000, and ISO 14000’, International Food and Agribusiness
Management Review 4, 67-79.
Chapter 8
Inspecting Aviation Safety in the EU:EASA as an Administrative Innovation?
Adriaan Schout Netherlands Institute of International Relations, Clingendael, The Hague
Introduction
Following regulatory theory as presented inter alia by Majone (1996, 2000;
Moran 2002), EU agencies can play major regulatory functions that could
lead to better policies. They can contribute to, among others, more
consistency between policies, providing the evidentiary basis of policies and
to better enforcement and greater transparency. Moreover, agencies can
support the EU administration through flexible and professional management
(Géradin et al. 2005). Their expertise and independent input is supposed to
lead to a depoliticisation of policy issues and may contribute to better risk
assessment and risk management as well as to greater transparency (Vos and
Wendler 2006).
However, as is becoming clear from recent reviews, EU agencies have
turned out to be rather different in practice (Craig 2007; Dehousse 2007;
Tarrant and Kelemen 2007). Most of them have become regulatory agencies
without regulatory powers (Majone 2005: 97). Although there are some
258 Adriaan Schout
powerful agencies, such as EMEA (medicines agency) and EFSA (food
agency), most have become primarily information-giving bodies (Géradin et
al. 2005: 71). Hence, EU agencies ended up in some sort of ‘in between
situation’. They are a nuisance to some who regard them as complicating
their traditional ways of working while others see them as insufficiently
developed compared to the position independent regulatory agencies could
occupy (Schout 1999a). In the midst of institutional pulling and hauling,
agencies have become too important and heavy for some but too weak for
others.
Nevertheless, it seems that agencies somehow seem to be able to carve
out an acceptable position in EU policy-making. They seem to emerge from
negotiation processes in which no one gets what (s)he wants but they are
nevertheless regarded as useful once in operation. This process of
institutionalisation of (EU) agencies has only just begun as a research theme.
In the wide set of variables that shape an agency, Selznick points in his
seminal work to the role of the Executive Director (1957). Others focus on
principal agency theories, political negotiations and institutional constraints to
explain the EU’s agencification (e.g. Moe 1987; Thatcher and Stone Sweet
2002; Kelemen 2002; Dehousse 2007).
Importantly, rational behaviour is one of the major driving forces in
these theories (Coen and Thatcher 2007; Tarrant and Kelemen 2007). In the
negotiations during the setup and in the subsequent negotiations in agency
boards and between agencies and Commission, the actors are assumed to
understand what it means to create an EU agency, to know their interests,
and to be able to create the appropriate conditions for agencies in terms of
budgets and other organisation conditions. These negotiations have led to
compromises that seem incompatible with the nature of independent
agencies. For example, most EU agencies have task descriptions that
underline their independence while having Management Boards filled with
Inspecting Aviation Safety in the EU 259
Member States meddling with many details of the agency’s daily business.
Even the term ‘Management Board’ used in some agencies is strange in view
of the fact that the executive director is supposed to be the independent
manager of the agency (Schout 1999a). Such outcomes are the result of the
negotiations between Commission, EP and Member States who, according to
the rational theories, strive for power, control and influence (Kelemen 2002;
Thatcher and Stone Sweet 2002; Dehousse 2007).
Having identified rationality as one of the core elements in EU agency
literature, this article examines whether the behaviour of the actors involved
in the set-up of agencies is indeed rational. Evidently, ‘rationality’ in public
sector processes is a complicated term and relates to questions such as
rationality in the interest of whom? For example, rational in relation to the
preferences of the public, the minister, or civil servants (compare Radaelli
and de Francesco 2007)? Given information constraints, are people at all able
to operate rationally (Simon 1976)? We understand rationality as the ability of
actors to identify their objectives and to gather the necessary information
about the variables involved (Denhardt 2007). With our interest being in
identifying the rationality in the process of institutionalisation, our objective
is rather limited. It is not our intention to examine whether alternative
models such as the garbage can model would be more appropriate to explain
the EU’s agencification (March and Olsen, 1976). Instead, what we really
want to know is whether the negotiators know what they are doing.
The focus of this Chapter is on the institutionalisation of EASA (the
European Aviation Safety Agency) and we will examine in particular the
elaboration of its inspection powers. EASA is an interesting case because it
was initially supposed to acquire major inspection powers, even though
Member States have been keen to respect the principles of subsidiarity and
their institutional autonomy. In general, enforcement is in the first instance
the responsibility of the Member States.
260 Adriaan Schout
The set up of EASA has been very ambitious and as such it shows the
trend within the EU of evermore and evermore powerful EU agencies
(Monda, Schout and Vos, forthcoming). It has been given semi-legal powers.
Some of its ‘soft measures are quite hard’ (as expressed in an interview). Law-
making is the responsibility of the Commission but the implementing
measures that EASA produces – often in the form of guidelines – are close to
obligations. Planes and organisations have to meet the requirements of the
guidelines. If Member States or national organisations opt for alternative
arrangements they have to obtain approval from EASA. Moreover, EASA
gives certificates to types of planes. This can have horizontal effects because, if
the certificate is withdrawn, this will affect all owners of such planes. Hence,
EASA measures border on rule-making. Furthermore, where EASA assists the
Commission in law-making, the Commission can not change the opinions of
EASA without prior coordination with the agency.
EASA’s prominence is also clear in relation to inspection and
enforcement. Originally, EASA was supposed to have independent inspection
powers. Moreover, to give EASA more of a bite and avoid time consuming
infraction procedures, it has been given the power to ask the Commission to
impose fines (in 2007).
Taking these powers together, it is clear that at its creation, EASA
implied a centralisation of tasks. Its creation was set in the context of moving
safety regulation and enforcement tasks from the NAAs (national aviation
authorities) to Köln.
This study addresses how these inspection powers have matured. Has
EASA developed into the powerful and centralized body it was supposed to
be at its inception? In other words, has EASA generated the major
institutional innovation in aviation inspection that it was intended to do?
How can this development be explained?
Inspecting Aviation Safety in the EU 261
To understand the development of its responsibilities, we compare key
texts which emerged throughout its institutionalisation process. These are
mainly the Commission documents for the creation of EASA,1 the Basic
Regulation (BR1592/2002)2 and the several drafts that were on the table
until the final adoption of its first task enlargement at the end of 2007. The
Finnish presidency in the second half of 2006 was particularly keen to finish
the negotiations in the Council with a political agreement. Although few
thought they would succeed, if only due to the many footnotes in the text,
the presidency achieved its objective among others by producing presidency
proposals without footnotes. This is already telling: Member States put a lot
of energy into the negotiations, coming with negotiation instructions and
scoring footnotes which were subsequently graciously removed en masse.
Secondly, throughout 2006 and 2007, close contact was kept with key
officials from EASA, the Commission, the European Parliament, the General
Secretariat of the Council, national ministries, permanent representations and
several NAAs. This made it possible to follow the negotiations and to unveil
the reasons behind the actions of the negotiators. The findings of the analysis
was checked by writing a report for the Dutch ministry for transport on the
development of EASA (Schout 2007a) and by discussing this report with the
various stakeholders.
In the remainder of this Chapter, we will first discuss the development
of EU agencies more generally and focus on the question of whether they are
mere quantitative developments of the EU’s toolbox or whether they change
the EU governance system more profoundly. The subsequent section
addresses the development of EASA more generally to better understand the
development of its powers. The next section discusses principles of
enforcement in the EU. This provides the basis for examining the
formulation of EASA’s enforcement role. Although this chapter deals with
the emerging pattern of EASA, the interviews also give insights into the
262 Adriaan Schout
agency’s effectiveness. A discussion of its operations, followed by a review of
the main arguments, concludes this Chapter.
EU Agencies: More of the Same or a New
Instrument?
It is important to understand the EU’s agencification and to understand their
institutionalisation because, as several interviewees in the EU administration
presented it: EU agencies are ‘mushrooming’. This is clearly visible in the
EU’s transport policy, where agencies have been created for aviation safety
and environmental standard-setting (EASA), maritime safety (EMSA) and rail
transport (ERA). Options for additional agencies are being discussed, such as
in the field of inland waterways and air traffic management (incorporating
Eurocontrol into the EU). This fits the general trend of ‘agencification’ of the
public sector more generally (Wettenhall 2005). Pollitt (2003: 6-7) defines
agencies as ‘functionally disaggregated’ from departments and enjoying ‘some
degree of autonomy’. Hence, this agencification is not intended to be just a
new instrument, but a change in governance towards granting a role to
independent expertise.
Limiting ourselves to the EU, agencies have been created for different
reasons. First of all, they are part of the governance debate which began at the
end of the 1990s and which addresses – among other things – ways in which
to accommodate the demands of technologically advanced societies. By
complementing political decision-making with expertise and independent
advice, agencies limit the freedom of politicians (as is the case with the
European Central bank, Majone 1996). Generally, due to their expertise,
agencies can be a major addition to political decision-making and thus
contribute to better (i.e. technical) risk assessment as part of the more political
risk management (Vos and Wendler 2006). Better monitoring and
Inspecting Aviation Safety in the EU 263
enforcement can be an integral part of risk assessment and management
strategies. Hence, agencies can contribute in different ways and to different
phases of policy-making (from ‘pork to fork’ as in the food safety). With this,
agencies are supposed to be more than just a new instrument – a quantitative
change in the EU's administrative structures – but potentially imply a
qualitative development of (European) administrative systems.
Moreover, new public management theories have fuelled agencification
and this has also affected the EU (Wettenhall 2005; Géradin et al. 2005).
Agencies offer private sector techniques and means of overcomeing public
sector constraints such as staff policies (limitations on payment, avoiding
tenure contracts, etc.). Although being far from happy with agencies, the
Commission embraced them often for pragmatic considerations, viewing
them as offering ways to circumvent its (human) resource limitations.
But there have been other pragmatic considerations. Some agencies
were created so that all heads of state could claim successes when European
Council meetings had to take decisions on the location of agencies (Schout
1999a). Other agencies were formed by accidents and crises that demanded
visible proof that the EU was dealing with the problems (Krapohl 2004). This
variety of backgrounds has contributed to major differences in terms of tasks
and operations of EU agencies.
One of the characterising features of EU agencies is that they are,
usually, a network organisation working closely with national capacities. An
EU agency is usually the organiser of the network. It seldom takes over tasks
from the Member States but instead provides a framework for cooperation
between national authorities. Subsidiarity-type network arrangements seem to
be the model for EU agencies (Everson et al. 1999; Chiti 2000). Agencies can
be created bottom-up, i.e. offering network-management to national agencies
(Schout 1999a). They can also be created top-down in the sense of breaking
up EU competencies. For example, competition policy was first highly
264 Adriaan Schout
centralised to the extent that DG Competition could be regarded as a very
powerful EU agency. To unburden the Commission and to build up
capacities for competition policy at the national level, the management of this
area was decentralised by creating national competition authorities which
cooperate closely within the European Competition Network (Wilks 2005).
This mushrooming is in many ways a remarkable development. Despite
a growing critique of agencies in the Member States and of EU agencies, we
nonetheless see ever more and ever stronger EU agencies being created
(Dehousse 2007) up to the point that the EP concluded that is hard to
establish how many agency-type arrangements the EU currently has (EP
2007). Moreover, although initially being heralded as solution for the EU’s
legitimacy crisis (Majone 1996), numerous critical assessments of agencies
have since been published. Firstly, there is a discussion about the true
advantages of agencies in general as well as of EU agencies (as expressed in
interviews with national and EU officials, but see also Monda et al
forthcoming). EU agencies and agency-type structures have been presented
as, inter alia, a sort of a ‘run-away bureaucracy’ (Martens 2005), as leading to
mono-dimensional expert values instead of to balanced policy judgements
(Chiti 2000), and as contributing to an expansion of the Commission’s
influence over Member States (Wilks 2005). Similarly, MEPs have warned of
a re-nationalisation of EU competencies and an uncontrollable and non-
transparent development (EP 2007). Academics have commented on the
limited extent to which agencies have been able to acquire powers in the
‘regulatory state’ (Moran 2002; Everson et al. 1999; Thatcher 2002; Géradin,
Munoz and Petit 2005: 71; Majone 2005). In short, EU agencies are one of
the most criticized elements within the EU governance debate.
Even though there is very little systematic analysis of the effectiveness
and efficiency of EU agencies, when it comes down to their contributions,
EU agencies seem to be doing rather well. Not one of the EU agencies is
Inspecting Aviation Safety in the EU 265
facing a fundamental discussion about whether it should be dissolved.
Agencies and agency-type network arrangements seem to fill gaps in national
networks and contribute to the need for more and better information and
analysis (Eberlein and Kerwer 2004). Moreover, there is a rather widespread
assumption that agencies have altered governance patterns (Coen and
Thatcher 2007).
Almost all agencies are regularly evaluated and such assessments are
generally very positive.3 Despite doubts about the appropriateness of the
influence of management boards, imprecise task descriptions in Regulations,
sensitive – if not hostile – relations with Commission and Member States, and
a lack of resources, EU agencies somehow seem to find their niches and to
develop effective patterns of functioning. The European Environment
Agency (EEA) is a case in point. It started as a truly chaotic body that
probably only few really wanted and which was partly created because it was,
in 1994, necessary to have enough agencies to satisfy each capital (Schout
1999a). Yet, upon its launch, the EEA in fact had many tasks to fulfil because,
rather than choosing between tasks, the Member States and Commission
simply added all the tasks that were mentioned during the negotiations;
moreover, it receives a small budget and has needed to work, in the course of
fulfilling its assigned tasks, with a wide range of very different national
agencies. Nevertheless, after a few years it became clear that the EEA was
developing into an organisation with a workable set of roles, a set of effective
work planning mechanisms and quality control procedures that no one could
have anticipated from the constituting negotiations. By now, the EEA is a
highly regarded organisation and its pronouncements are widely quoted in
policy and academic documents (Hoornbeek, 2004; Jordan and Schout 2006).
Despite these successes, one can wonder whether the EEA is something
‘new’. It produces reports that, to a large extent, could have been presented
by consultants and national agencies or similar bodies (which now work with
266 Adriaan Schout
the EEA). The added value of the agency structure therefore remains in
doubt (Schout 1999a). It has not developed into the independent regulatory
type of body that is usually associated with the agency concept. That does not
mean that the EEA underperforms but it shows that its role has been limited
to information gathering.
The fact that EU agencies seem to be functioning rather well albeit that
they do not seem to be revolutionary – leaves us with a fundamental
question: why are there so many complaints about EU agencies? The answer
may be that for those who had hoped that agencies were something new, the
agencification of the EU is disappointing as it fell short of the regulatory
agencies more common in the US (Everson 2001). Alternatively, for those
less convinced of the need to create independent bodies, the new agencies
add little or even tend to complicate the EU’s traditional policy-making
mechanisms. The latter view has been often expressed in interviews with
practitioners in several EU agency studies (Schout 1999a; Schout 2007a).
EASA – A Coincidental Success
Development of the EASA System: from ICAO, via JAA to EASA
EASA is a good case to study the institutionalisation of an EU agency. It was
originally intended to be centralized – taking over national tasks – but it
ended up being rather ‘more of the same’ (Schout 2007a). Although creating
fears that it would take over tasks from NAAs, it has barely done so (thus far).
Nevertheless, it may have been one of the contributing elements to the
improvement in aviation safety, even though it also failed to develop into the
regulatory agency that one would expect on the basis of (Majone’s)
regulatory theories. Despite its centralized origin in relation to rule-making
and enforcement, it has developed into the network-type arrangement rather
similar to what seems to be the normal pattern for EU agencies (Everson et
Inspecting Aviation Safety in the EU 267
al. 1999; Chiti 2000) and similar too to the situation that existed in the EU’s
aviation safety organisation prior to the establishment of EASA (Schout
2007a).
A milestone in the history of aviation safety was the ICAO agreement
(International Civil Aviation Organisation) dating back to the Chicago
Convention in 1944. ICAO sets minimum standards that have to be
implemented at the national level. To date, ICAO knows only Member
States and has no supra-governmental representation. In other words, the EU
is not a formally recognized actor but this may change in the future and with
this, EASA’s involvement in ICAO may become a more direct one (Schout
2008). In Europe, countries were working towards harmonisation of cross-
frontier air traffic on the basis of JAA standards. ICAO related work was
arranged through the pan-European Joint Aviation Authority (JAA), through
which the national aviation authorities from 39 countries were organised.
ICAO also has an inspection mechanism based on visits, reporting
procedures and follow up inspection visits. In the light of heavy criticism of
ICAO, these reports are now increasingly made available to the public with a
view to transparency and sharpening peer pressure. Within Europe, JAA had
organised these inspection tasks. When EASA was created, it took over these
inspection tasks from JAA together with the regulation tasks.
The problems with JAA were many and proved that it was not the
basis for liberalisation of the EU’s aviation sector. The situation resembled the
conditions in other economic sectors in which EU agencies had been created.
There were many delays in agreeing on rules implementing the JAA
objectives, a lack of commitment from member countries towards the JAA’s
non-binding legislation, industry being faced with many different national
requirements, and unanimity voting preventing clear legislation and resulting
in protracted decision-making (e.g. CEC 2000a). One indication of the
existing fragmentation was that one Member State estimated that it had
268 Adriaan Schout
modified approximately 4000 of the JAA rules in the national implementation
process (interview in 2007). Moreover, there were inspection difficulties due
to the sensitivities of inspecting each other’s planes and maintenance bodies.
Grounding an aircraft from major economic counterparts or from countries
with sensitive political relations was not an option. For example, any country
taking measures against the USA would have to be prepared for counter
measures. Similarly, Belgium grounding planes from Congo would be rather
problematic.
Moreover, as interviews show, the costs for industry of going through
25-27 different procedures in the EU were enormous, especially in view of
the fact that a plane consists of thousands of parts. Each individual part has to
be certified and these certifications have to be regularly reviewed. More
concretely, the development of the Airbus 380 demanded quick market
access while costs of certification had to be kept within competitive margins.
During the 1990s, the Commission became more involved in aviation safety
but a fully developed department for aviation rule-making and enforcement
was not feasible. Enlargement imposed severe limits on the Commission’s
abilities to take on new tasks. Hence, the search was on for an alternative
solution.
The option that was initially considered for stabilising aviation safety
was to make the JAA’s work binding through a pan-European treaty. The
choice for the agency format was not immediately evident and in the 1990s
the mood within the Commission was not in favour of yet another agency.
One of the sources of resistance to agencies was the threat they posed to the
roles and powers of the Commission.
However, due to the personal preferences of the relevant Director
General in the Commission, Mr Lamoureux, the treaty plans were
abandoned in 1999 and the proposal for EASA emerged with record speed
soon after that in 2000 (CEC 2000a, 2000b). In interviews, Mr Lamoureux
Inspecting Aviation Safety in the EU 269
was described as ‘a federalist’ who wanted a strong EU solution. He was even
characterized as an ‘enemy of intergovernmentalism’. Moreover, he was in
favour of agencies more generally. The change in preference signifies a move
away from a more intergovernmental pan-European solution with an unclear
role for the Commission towards an EU arrangement with a strong agency.
This move paralleled concerns in some Member States that did not want to
manage yet another treaty through their Parliament. With this coincidental
dislike of handling treaty negotiations, the Member States also began to take a
more relaxed view of the agency solution, making it possible for the
Commission to propose an agency.
But there were other reasons for the decision to create a strong agency
and for centralising tasks within the EU. The problems created by the loose
JAA structure had resulted in a broadly shared belief that Member States had
to be put at a distance. Aviation policy was politically too sensitive and
Member States could not be trusted to loyally implement JAA standards. The
incentive to impose rules that favoured their carriers or airports was too great.
The aim of avoiding governmental micromanagement also affected the
position of the Commission and supported the argument for an independent
agency outside Brussels. Furthermore, the industry itself wanted an efficient
and effective system, and feared continuous pressures and interference from –
in particularly – the major aviation countries. A situation had to be created
that would not lead to extra powers for the big countries.
Finally, inspections of foreign planes can be very sensitive and Member
States have shied away from such measures for fear of eliciting retaliation or
of endangering international relations. Hence, a system based on collective
oversight and European enforcement powers was seen to be the wiser
approach to the inspection of foreign planes.
270 Adriaan Schout
As a result of these pressures and convictions – and despite legal
doctrines such as the Meroni principle – the EU seemed ripe for a strong
agency with rule-making and enforcement powers.
Early Years
Starting in Brussels in 2003, EASA opened in Köln in 2004 and was supposed
to acquire a staff of approximately 600 full time positions. The starting up
phase was extremely difficult. As a result of the unavoidable looseness of
drafting in the Basic Regulation (1592/2002), there were many issues to be
settled including the question of how to organise inspections, who would be
allowed to work on the inspection teams and what kind of transparency
would apply to inspection reports. The agency also had to learn the hard way
that it could not expect to have 600 staff at its disposal in the foreseeable
future. Therefore, it could not operate independently from the NAAs but
instead remained highly dependent on national capacities.
Hence from the start, there was a clash between centralisation (moving
tasks to Köln) and decentralisation (subsidiarity or network-type arrangements
with NAAs). The result was a potentially dangerous confusion. Member
States were under the assumption that they could discontinue certain actions
while EASA lacked the budget to hire sufficient people and, more
importantly, has had to comply with the EU’s complicated hiring
arrangements. In order to avoid situations in which agency staff automatically
become EU staff (with all the benefits that such status entails), agencies are
only allowed to hire on the basis of temporary positions, and these temporary
employees are paid as junior officials (Pereyra forthcoming). Hiring a test
pilot on the bases of a junior EU official salary proved difficult, and seconded
EU officials on temporary contracts were happy to move back to Brussels
(Schout 2007a). This, plus the fact that Köln lacks the prestige and
international facilities (e.g. schools) to attract staff, has prevented EASA from
developing the expertise needed for its work.
Inspecting Aviation Safety in the EU 271
As a corollary, it seemed likely that the total amount of expertise in the
EU would go down rather than increase because of the lack of resources and
inadequate staffing policy. NAAs started to provide less services whilst EASA
was not yet able to take over. The House of Commons Transport
Committee issued a highly critical report in October 2006 (The House of
Commons Transport Committee 2006), which subsequently made the BBC
news with the headline ‘EASA threatens aviation safety in the EU’.
There were other threats to the effectiveness of EASA. EASA’s
Management Board did not grant the agency a realistic budget. Although
EASA is formally financially independent (Articles 12 and 24 from the
preambles (BR1592/2002)), the Commission and the Member States in the
Board decide, on the one hand, on the budget of the agency and, on the
other hand, also decide on the fees paid to NAAs and on the cost to industry
of their certificates. Clearly, these numbers did not add up and the resulting
losses have been compensated from the EU budget. The fees that EASA
needed to pay to the NAAs for the expertise it hired (set by the Board in
which NAAs are represented) did not match the prices that EASA was
allowed (by the Board) to charge industry.
Furthermore, without time to establish itself properly for its first set of
tasks related to the certification of types and planes, EASA has been
undergoing several task expansions. The original proposal from the
Commission was that EASA would have a wide set of responsibilities (CEC
2000b). The tasks of EASA were formulated in the original Basic Regulation
of 2002 and these already encompassed certification of products, persons, and
organisations. Its first tasks involved the certification of design, production,
and maintenance of planes. The first revision of the Basic Regulation in
2005-2007 elaborated the rules and principles for the regulation of personnel
and organisations. The second revision – now on the negotiation table – deals
with the operation of airports and air traffic management (taking over certain
272 Adriaan Schout
regulatory tasks from Eurocontrol). These ongoing negotiations have also had
a major influence on its roles and operations in relation to rule-making and
rule enforcement (see below).
Therefore, the way in which the agency actually came into being was
to a considerable extent guided by chance. Despite the ‘good’ intentions of
creating a centralised and strong EU agency, the negotiations did not address
fundamental issues such as budget and personnel policy or relations with
NAAs; as a result, EASA had to find idiosyncratic solutions to each of these
problems as they arose. Moreover, EASA – already overloaded – is now
being confronted with successive waves of task expansions. Furthermore, the
Member States were happy to hand over the responsibilities encased in the
first set of tasks. It is expensive for any Member State to host the expertise to
certify the design of an Airbus. However, when they realised that an EASA in
full operation would also assume other tasks, the interest in a centralised
agency dwindled (Schout 2007a). The full implications of EASA were not
clearly identified by the Member States.
EASA’s Enforcement Powers
Enforcement within the EU
Enforcement encompasses the monitoring of implementation and the
sanctioning of irregularities. Enforcement has been a sensitive area in the EU
due to the political and economic interests at stake for the Member States as
well as in relation to respecting national administrative structures for
implementation and enforcement.4 It is not simply sensitivities that have
preserved the national inspection powers. One of the principles of good
governance is the principle of subsidiarity (CEC 2001) and this has
implications for the way in which the EU organises enforcement. A general
Inspecting Aviation Safety in the EU 273
starting point for inspection is that the rules are formulated at EU level, but
inspection builds on the principle of the EU's shared EU legal system. In
general, the Member States are responsible for enforcement. They are
expected to monitor implementation and sanction irregularities. This is a
fundamental principle of shared competences between Commission and
Member States. Another principle guiding the enforcement of EU legislation
is that the level that issues the rules is responsible for its implementation. As
EU legislation is often of the sort that sets objectives while leaving the
implementation of the Acts to the Member States, it is therefore the national
administrations that are in charge of monitoring and enforcing policies, with
the European Commission monitoring national enforcement and holding
overall responsibility to see that enforcement takes place.
Over the past few years, major developments have taken place in
enforcement in terms of the creation of new instruments and reinforced
arrangements. However, EU lawyers still speak of a ‘European enforcement
deficit’ (e.g. Jans, De Lange and Widdershoven 2007). There are various
reasons for the difficulties in enforcing the implementation of EU policy.
Trust is a key issue. Member States have a shared responsibility for
enforcement. Enforcement is a collective good and, as to be expected with
collective goods, countries have incentives to economise on investing in it.
The internal market depends upon the way in which the Member States
build up monitoring and sanction systems. However, effective monitoring
may bring national administrations into trouble with the Commission; it may
have economic and political costs, or – as is the case with aviation safety – it
may lead to international trade retaliations. Hence, if Member States are
under the impression that their fellow administrations do not take
implementation and enforcement seriously, they themselves may not take
their obligations seriously either.
274 Adriaan Schout
To smoothen over enforcement problems, the EU has employed a
range of alternative options including soft modes of governance aimed at
creating a greater sense of ownership of obligations and at creating peer
pressure to implement (Knill and Lenschow 2000). Furthermore, a range of
cooperative arrangements has been created to support coordination and the
sharing of information between the Member States and with the Commission
(Jans et al 2007: Chapter 6). Moreover, the involvement of the EU in
prescribing control methods is increasing, as is inter alia underlined by the
requirements in the EU’s energy policy that Member States must establish
independent energy regulators (Schout 2007b). In other areas, the
Commission has gained the power to visit and inspect sites on its own
initiative. This is particularly the case in food safety.5 Where the EU’s
finances are involved, an independent authority – the Office pour la Lutte
Anti Fraud (OLAF) – was created in 1999, which also has autonomous
investigation powers.6
Hence, on the one hand there has been an increase in the development
of enforcement mechanisms in the EU. On the other hand,
Communitarisation has remained the exception and has developed mainly in
relation to food safety and financial programmes. In general, enforcement has
remained a shared responsibility between Member States and Commission.
The principles of subsidiarity and national institutional autonomy, as well as
the national sensitivities and fears of losing powers, will probably prevent a
swift development towards Communitarisation of inspection and
enforcement.
This stands in rather strong contrast to the way in which EASA was
originally perceived. Given the serious challenge of ensuring aviation safety,
EASA was intended to, among other things, centralise enforcement powers.
As our interviews showed, some have even wanted to include a separate
EASA-court in the definition of its enforcement tasks, which would be
Inspecting Aviation Safety in the EU 275
independent of the (limited) resources of the Commission for such a
specialised monitoring role.
The Development of EASA’s Inspection Powers – From Intentions to
Reality
Due to the sensitivities of inspections, the EU suffered from an unsatisfactory
inspection system. Given the widely shared frustration with the EU’s internal
market for aviation, the political climate was ripe for a Commission proposal
in 2000 that stated that the agency may ‘investigate’ and centralise inspection
powers (Art. 45, CEC 2000b). Given the broad set of tasks, the investigative
powers of EASA were intended to be rather encompassing. Article 1 of the
Regulation 1592/2002 indicates the tasks of EASA:
‘This Regulation shall apply to:
(a) the design, production, maintenance and operation of aero-nautical
products, parts and appliances, as well as personnel and organisations
involved in the design, production and maintenance of such products,
parts and appliances;
(b) personnel and organisations involved in the operation of aircraft.’
EASA’s tasks, each with its own origins and sensitivities, have been elaborated
in the subsequent proposals from the Commission. The process of defining
the responsibilities for EASA – and with that also the tasks of the NAAs – is
still ongoing but the direction in which the various tasks related to
certification and inspection is going is as follows:
- The certification of types has now been handed over to EASA. This
involves the approval of types of aircraft (e.g. the Airbus 380) and of
products (e.g. gearboxes). Due to staff and budget shortages, EASA hires
experts from the NAAs. As the types are approved by EASA, it also
inspects the designs and the final products.
276 Adriaan Schout
- Supporting the Commission in rule-making. EASA proposes opinions to
the Commission. Without altering the content, the Commission presents
these to the committee on aviation safety. As such, this is a rather
traditional comitology type of rule-making system, in which national
experts figure prominently both in rule drafting and in deciding on the
rules (Schout 2007a).
- The certification of planes. The certificates for individual planes are issued
by the home country. Is involves the implementation of the rules defined
for planes and is therefore a national responsibility.
- The ramp inspection of planes from within the EU will be done by the
NAAs. Since certificates of planes are the responsibility of the national
authorities, the NAAs will inspect the planes. EASA monitors the
procedures of the NAAs.
- The Commission – through EASA – monitors the quality of the NAAs
and the extent to which they live up to the rules and requirements of
aviation. This is the inspection role of EASA.
- The ramp inspection of foreign planes is also done primarily by the NAAs.
- The inspection of other organisations is divided between EASA, NAA and
qualified entity.
The above implies that, in the end, the way in which inspection powers are
distributed and the various roles of EASA vary considerably, and, as will be
discussed below, so does the organisation of these powers. As this list shows,
EASA has not become (so far) the centralised body it was intended to be.
During the negotiations on the precise formulation of EASA’s
inspection powers, crucial questions emerged over whether EASA was
allowed to do ramp inspections and whether it could inspect foreign planes.
This resulted initially in the modification in the Basic Regulation that
provided that EASA would ‘assist’ the Commission. The consequence of this
reduction of the role of EASA is that the inspections are seen as more
Inspecting Aviation Safety in the EU 277
political and less technocratic. The Commission is regarded as a more
political body than the agency. The formulation suggests that the
Commission, as the recipient of the inspection report, can be influenced
more easily than the experts from EASA. Hence, in the end, it is not up to
the agency to investigate Member States or to publish its findings
independently.
There are several references to inspection in the Basic Regulation of
2002, which followed from the original Commission proposal (CEC 2000b).
These give ‘EASA’ far-reaching responsibilities. However, as often with EU
agencies, a distinction has to be made between the agency and the agency
system.7 Albeit that ‘EASA’ has several roles, the implementation of the
Regulation may turn out to be more complicated than assigning full
responsibility for these tasks to the agency. The Regulations and their drafts
speak in several places of ‘inspections’, ‘continuing oversight’, ‘monitoring’.
Some examples taken from the original proposal from the Commission and
the Basic Regulation, which resulted from this, include:
- Art 5 (BR1592/2002) defines the rules for airworthiness certificates for
individual planes. Following the principle that who regulates – i.e. issues
certificates – should also be responsible for enforcement, this Article
suggests that EASA has inspection powers in relation to individual planes.
It should, however, be noted that this article does not specify who does
these inspections.
- Art 12 on the functions of EASA: 12.2.d (BR1592/2002): ‘conduct
inspections and investigations as necessary to fulfil its tasks’ (note the open
ended wording).
- Art 15.2. on the provision of certificates (BR1592/2002): ‘The Agency
shall: conduct, itself or through national aviation authorities or qualified
entities, technical inspections associated with products, parts and appliance
certificates’.
278 Adriaan Schout
- Art 15 (CEC 2000b): ‘issue the appropriate type certificates [granting type
approval for products and appliances], including the certification of design
organisations … and ensure continuing oversight’.
- Art 16.1 (CEC 2000b): ‘The Agency shall conduct inspections’ of the
application by the Member States. It also underlines that it ‘shall report to
the Commission’.
- Art 16.2 (CEC 2000b): ‘The Agency shall conduct technical
investigations…’
- Art 29 (CEC 2000b): specifies the tasks of the Executive Director and
specifies that he decides – ‘completely independent’ – on ‘inspections and
investigations’ (as provided in Art 45/46 on inspections of Member States
and of undertakings).
- Art 45 (BR1592/2002) presents the way in which EASA may inspect
NAAs
- Art 46 (BR1592/2002) indicates that EASA or other bodies (NAAs,
qualified entities) may inspect national undertakings.
This gives an indication of the remarkable inspection potentials EASA was
granted at the beginning of its life. Given the general impression of
governmental failures during the JAA era, these ambitions were broadly
supported by the Commission, industry and Member States. Part of this
national support was related to the fact, around 2000, some Member States
were in the process of privatising tasks aviation related tasks. It was also hoped
that some aviation safety tasks could be dropped due to the creation of EASA.
However, in addition to these ambitions, the proposal from 2000 and
the Basic Regulation from 2002 also left ‘too much’ undecided (interviews)
and required further precision by the Commission in the follow up proposals
and by the Board.
Meanwhile, Member States had started to doubt whether the creation
of EASA was such a good idea after all. The (first) revision and the extension
Inspecting Aviation Safety in the EU 279
of the Basic Regulation in 2005-2007 elaborated the rules and principles for
the regulation of personnel and organisations involved in aviation (CEC
2005b). The second revision, now on the table, deals with air traffic control
and operations of airports. In other words, the first set of tasks that EASA
received concerned the certification of the hardware (types of planes by
EASA and of individual planes by Member States). The first extension
concerned the people (pilots and crews) and organisations (operators). The
second extension deals with the regulation of air traffic management and of
airports. These expansions and the negotiations that they involve, as well as
the decisions that were taken by the Board, have modified EASA’s original
design in fundamental ways.
The Influence of the Negotiations on EASA’s Task Description
The Commission proposal and the Basic Regulation suffered from unclear
language and created considerable tensions between Member States, EASA
and Commission. The interviews revealed that the motives of the negotiators
included an ambition to guarantee aviation safety, to negate the threat to vital
national economic interests involved in loosing control of ramp inspections
and decisions on grounding airplanes, and to ensure tasks for NAAs.
Evidently, these ambitions have been conflicting.
Proposals for revision and elaboration of the Basic Regulation of 2002
and the proposals for operating rules in relation to specific articles in the Basic
Regulation have been presented by EASA to the Commission. It is the task
of EASA to present opinions to the Commission. As far as rule-making is
concerned, the Commission consults the EASA committee. Proposals for
changes to the Basic Regulation are presented to the Council and European
Parliament.
The results of the negotiations as they stood at the end of 2007 show
how the various interests have been brought together. Firstly, the wording of
280 Adriaan Schout
the original 2000 proposal for Article 15.a – which defines the tasks in
relation to certification of products and appliances – is ambitious: ‘The
Agency shall conduct, itself or through qualified entities, technical inspections
required to check that their type is air worthy, in accordance with the rules
adopted in respect of the design…’.
Art 15.b continues that the agency shall ensure continuing oversight.
This has been watered down in the version that was agreed in the working
party to: ‘the Agency shall… conduct, itself or through national aviation
authorities or qualified entities, investigations associated with products, parts and
appliances certifications’.8 This is a downgraded version compared to the
document on the negotiation table at the end of the negotiations in the
Council, which still read: ‘inspection and audits’ instead of ‘investigations’.9
Similar changes were introduced in relation to the articles on the certification
of personnel, organisations and third country operators (Articles 21-23).
These changes underline that the creation of inspection powers has
remained sensitive. The Member States, despite their original support for
centralisation, were not inclined to hand over inspection tasks when the
proposals were discussed article by article. It also shows the efforts the
Member States have made to re-insert their NAAs where possible. Similarly,
the ‘qualified entities’ referred to above were already in the Commission
proposal in order to allow Member States to maintain their traditional
national structures. Some Member States had organised certification tasks
through private sector bodies (qualified entities) and had insisted that these
should be able to carry on their tasks as before. Although in favour of a strong
agency, article by article, the Member States incrementally protected the
status quo.
Inspecting Aviation Safety in the EU 281
The Development of EASA’s Monitoring and Investigation Powers
Article 16.1 (CEC 2000b) deals with monitoring the application of rules and
specifies that EASA ‘shall conduct inspections to verify the application by the
Member States’. After the negotiations in 2006, it read ‘The Agency shall
conduct standardisation inspections in the fields covered by Article 1(1), in
order to monitor the application by national competent authorities …’.10 These
changes specify that the agency is not going to take over the role of the
national authorities in terms of inspecting planes, but is mainly to function as
an ‘inspector of the inspectors’.
Similarly, Article 46 in the Commission proposal (2000) states that:
‘Without prejudice to the enforcement powers conferred by the Treaty to
the Commission, the Agency may undertake all necessary investigations and
inspections for the purpose of carrying out the duties assigned to it by this
Regulation’ (emphasis added). As regards the role of NAAs or other bodies,
the 2000 proposal specified that the manner of co-ordination with the
national bodies was to be determined by EASA: ‘it may also allocate
investigation tasks to qualified entities in accordance with the guidelines to be
adopted by the administrative board…’ (Art. 46). This was changed in 2006
into ‘the Agency shall assist the Commission in monitoring the application of
this Regulation and its implementing rules, by conducting standardisation
inspections of Member States’ competent authorities as specified in Article 24(1)’
(Article 53 on the working methods for inspections of Member States;
emphasis added). This change not only brings the ‘competent authorities’
back in, but it also shows that the Member States prefer the Commission to
be in the lead when it comes to actions on the basis of the inspections.
Further, when it comes to investigations by private sector bodies
(‘undertakings’), Member States were keen to reinsert their national aviation
authorities. The relevant Article from the Commission’s proposal to establish
common rules in the field of civil aviation and creating a European aviation
282 Adriaan Schout
safety agency (Article 48 Investigation of undertakings) reads:
‘…investigations of undertakings shall be undertaken by the Agency or by
qualified entities’. This has been changed into: ‘The Agency may itself
conduct or allocate to national aviation authorities or qualified entities (Article
46 2006).
The guidelines that the Board has to adopt – referred to in Article 46 –
specify the conditions for when and how to inspect the NAAs, as well as the
details of what to do with the inspection reports and how to financially
compensate for experts from other national bodies that involved in the
inspections (inspection as network activity). The investigations of Member
States and undertakings have to be announced in good time and Member
States are obliged to assist these inspections. As it now functions, the
inspection reports go first to the Commission for follow up actions. The full
reports are not made available to the public.
These changes had restored the general principles of subsidiarity and
enforcement autonomy. Moreover, the individual articles had been diluted so
that NAAs and other national bodies would remain involved and to ensure
that responsibility for follow-up measures were attached to the more
politically sensitive Commission. On the whole, what has emerged is a rather
traditional inspection pattern with a central role for the Commission. More
worryingly, with the inspection reports not being available to the public, the
system lacks openness and transparency (Schout 2007a, 2008).
This was not enough for the Member States. The negotiations on
EASA were, by the end of 2006, rather tense. The Member States wanted
more reassurance that they would remain responsible for the inspection of
planes. Hence, to prevent final problems in reaching a political agreement in
the Council, the Commission issued a ‘Unilateral statement’ in the final
document for the Council (13 December 2006) relating to EASA’s inspection
Inspecting Aviation Safety in the EU 283
powers, which emphasises that EASA will not threaten national inspection
responsibilities (emphasis added):
‘The Commission confirms that the text … does not change the current role of Member States both as regards their primary oversight role over undertakings under their responsibility, and as regards ramp inspections including decisions on grounding of aircraft. These provisions simply add the possibility for the Agency to carry out inspections of aircraft for the purpose of: - Certification procedures carried out by the Agency...; - Inspections of any undertaking ... in cooperation with Member
States. Article 7 explicitly limits the possibility to ground aircraft to Member States only. Under no circumstance can the Agency ground an aircraft. The Agency's role – when a safety deficiency is found – is to inform the Member States concerned and the Commission of such a deficiency. The Agency's power to act is limited to the withdrawal/suspension of certificates/authorisations it has issued.’
What these changes add up to is a series of compromises that have re-inserted
maximum flexibility for the Member States. The Member States are to
remain in charge of inspection and enforcement while the Commission – in
this case through EASA – is to be the inspector of the inspectorates in
accordance with the traditional division of inspection roles (Jans et al. 2007).
A Note on the Effectiveness of EASA’s Inspection Powers
Although the objective of the study is to understand the drift in agency
design, the interviews also gave insights into how practitioners evaluate the
effectiveness of the aviation inspection system. Evidently, an evaluation of the
operations of a public sector body – including its efficiency – would require a
much more in-depth analysis (e.g. Powell 1987). Nevertheless, the interviews
give some indications of what the findings might be. The first finding in
relation to the operation of EASA is that the JAA system that preceded it is in
several ways still highly regarded. As regards rule-making, the current
regulatory system is still largely based on JAA’s output.
284 Adriaan Schout
Moreover, the experts from the NAAs that cooperated in the JAA now
cooperate with EASA in rule-making and with inspections. Hence, as regards
inspection, EASA resembles the JAA system. What is different is that the
Commission can take decisions on the basis of the reports and if necessary
plan follow up visits or take the NAAs to court. In addition, EASA has a
department for supporting capacity building of NAAs.11 Hence, it puts more
effort into building up the capacities of the EASA network than the JAA was
able to do.
Thus, there has been considerable continuity in terms of expertise and
the networks involved. EASA’s success is mainly the success of integrating the
non-binding JAA rules into the EU legal system. This, as such, has little to do
with EASA. What is different is that the Commission has a stronger
organising voice within the network of NAAs and it can take Member States
to court.
As regards openness and transparency, one of the arguments for
creating EU agencies, EASA shares characteristics with its predecessor (JAA).
The inspection reports remain unavailable to the public. They are addressed
to the Commission for decisions on follow-up actions. This compares poorly
to the Commission’s good governance principles (CEC 2001), as well as to
ICAO’s inspection system.
Therefore, following the distinction between risk assessment and risk
management, EASA does not seem to be an improvement on the JAA system
in relation to risk assessment – which was always rather effective. It is the
same experts working together, and they have always been highly focused on
safety and independence. The big difference is that aviation safety is a
Community competency with binding legal force, which moves enforcement
beyond soft power. Hence, risk management has improved by being brought
under the Commission’s authority. Risk management has also improved
because the Commission now operates with a Database in which the NAAs
Inspecting Aviation Safety in the EU 285
have to report the results from their inspections of the planes.12 This system
allows the Commission to spot problems with operators on an EU scale. This
helps to identify the weak players and, because it is a tool of the Commission,
it prevents inspection becoming an issue of one Member States against
another country. In other words, the gains relate to the Commission and less
to EASA. However, transparency of inspections has not improved.
In sum, the main advantages relate to the Communitarisation of
aviation safety and not primarily to the agencification. EASA has found its
niche. It organises and provides expertise, and it manages the inspections.
The system as a whole functions rather well – although transparency could be
improved – and it shares characteristics with the previous JAA system.
Conclusions
Following regulatory theory, EU agencies can undertake major functions
leading to better policies: more consistency between policies, evidence-based
policies, greater transparency, and better consultations. Agencies could
support the EU administration with specialised expertise and flexible and
professional management (CEC 2001). Their independence and expertise
may lead to the de-politicisation of policy-making and contribute to better
risk assessment and risk management. Clearly, the trend towards
agencification is visible in the EU and there are signs that agencies are
becoming ever stronger. The European Aviation Safety Agency (EASA) is a
case in point, with its in deep involvement in both hard and soft regulation
and in enforcement.
In several ways, this development is remarkable given that
agencification has been one of the more sensitive issues in the EU as it relates
to the distribution of tasks and powers between the Commission and the
Member States. Moreover, in relation to rule-making and enforcement,
286 Adriaan Schout
agencies are not just more of the same but potentially change the
administrative-political landscape by depoliticising rule-making and
enforcement. In relation to enforcement, this can have major consequences as
the Commission could be much more inclined towards acknowledging
political sensitivities than an agency that is driven by expert judgements.
Moreover, enforcement in the EU is strongly based on the principles of
subsidiarity and administrative autonomy. EASA, as initially conceived,
would have meant a leap away from these EU traditions.
In general, EU agencies have so far not acquired the position as
foreseen in regulatory theories. Majone (1996) posited that the expert power
organised in and around the agency will lead to a growing power of the
agencies, akin to spill-over predictions derived from functionalist theories.
Dehousse (2007), however, notes that the current positioning of agencies has
already existed for quite some years and that any rationalisation of the
disorganised position of EU agencies is likely to meet strong resistance (see
also Craig 2007). As it has turned out, EU agencies are kept on a leash. On
the other hand, those in favour of traditional majoritarian policy-making find
EU agencies too powerful.
Presumably, the debate on EU agencies reveals some tendency towards
image building. Some see major EU failures and call for independent
agencies. Others regard agencies as a threat to traditional power positions.
EASA was first assumed to be needed due to failures in the previous more
intergovernmental way of working. Our assessment, however, is that the
previous system was not that bad. In rule-making it was quite effective.
Enforcement was the JAA’s greatest weakness but EASA’s inspection regime
simply repeated the weaknesses of the previous system. What actually
improved inspections were the powers of the Commission and much less the
creation of EASA per se.
Inspecting Aviation Safety in the EU 287
EASA turned out to be weaker than originally planned. It has been
developed through the elaboration of its tasks by the adaptations in its Basic
Regulation and through the decisions taken in the Board. A pattern can be
seen in these developments. In relation to inspection, the original plans of the
Commission to centralise tasks in Köln have been watered down and
opportunities have been opened up for NAAs and national qualified entities
to remain involved in the inspection process.
The explanation for this dilution includes, firstly, the fact that Member
States were initially happy to drop some tasks in relation to aviation safety,
particularly where it concerned the certification of aircraft design. However,
when the Member States realised that this agencification would set a pattern
for the subsequent phases of EASA’s task expansion including inspection, the
earlier enthusiasm for an agency diminished. Secondly, the Member States
feared the independence of EASA in relation to inspection and enforcement.
The Member States were more at ease with keeping inspection as a national
task and ensuring that the Commission – through EASA – would take charge
of inspecting the inspectors.
Thirdly, the interviews showed that the agency concept was not clear
to those involved in the negotiations. Most of the negotiators and the dossier
managers in the capitals were not familiar with what an agency is, how it
operates and what consequences it might have for policies and inspections.
Hence, establishing an ‘agency’ as such was not part of the negotiations so
that the hundreds of footnotes that the Member States inserted to the various
Commission proposals all brought EASA back to a situation that was quite
close to how aviation safety had always operated. Related, the Member States
regarded the agencification of aviation safety apparently not as a positive sum
game in which new structures were created to change the polity by giving
independent expertise a bigger role, but as a negative sum game.
288 Adriaan Schout
Theorising on the basis of this N=1 case study about the
institutionalisation of EU agencies, our conclusion is that the negotiations can
only very partly be termed ‘rational’. On the one hand, the negotiations were
rational as Member States tried to preserve powers, discretion and
employment. The Commission – not in the position to absorb the tasks
related to aviation itself – tried to bind the hands of the Member States by
creating a strong agency.
On the other hand, the negotiations were far from rational. Firstly,
there was very little hard analysis of what the problems with the JAA system
were and what alternatives were available. The plans to centralise tasks in an
agency were quickly written. The overall ambition was, initially, to remove
the competences from Member States and to depoliticise the decision–
making process. The step-by-step approach of the creation of EASA, with a
first phase in which EASA would take care of type approval – an expensive
task for countries individually – made Member States willing to give up
certain roles. However, the realisation that other powers would follow suit
eroded the enthusiasm. Moreover, the incremental article-by-article
negotiations in the Council were not linked to an overall objective or model,
and the motives at play during the negotiations were conflicting.
Furthermore, such an incremental approach was not needed to dilute EASA’s
inspection powers. Had a few general enforcement principles been agreed
upon, such as the principles of subsidiarity and the institutional autonomy,
then the responsibility of Member States to ensure their own implementation
and enforcement systems would have been guaranteed.
These sometimes idea-less negotiations can be seen throughout EASA’s
short history; for example, the way in which prices and fees for experts were
determined so that EASA became highly loss-making. Moreover, the result of
the negotiations is an inspection system that is not too different from what
existed. EASA has not been the innovation that could have been expected
Inspecting Aviation Safety in the EU 289
from an agency. Given the fact that other agencies have similar problems
(Monda et al, forthcoming) and are created in much the same way by
negotiations between officials not schooled in creating independent agencies,
the conclusions of this case study may have wider relevance.
Notes
1 CEC, Commission of the European Communities, Commission working document in view of the
discussions within the Council on the creation of the European Aviation Safety Authority in the
Community framework, COM(2000) 144 final, 21 March 2000, Brussels; CEC, Commission of the
European Communities, Proposal for a regulation in the European Parliament and of the Council on
establishing common rules in the field of civil aviation and creating a European aviation safety agency,
COM(2000) 595 final, 4 December 2000, Brussels. 2 Regulation (EC) No 1592/2002 of the European Parliament and of the Council of 15 July
2002 on Common rules in the field of civil aviation and establishing a European Aviation
Safety Agency, OJ L 240/1. 3 There is mostly sketchy information on the effectiveness and efficiency of EU agencies. Each
EU agency has a website on which evaluation reports can be found. Evaluations are however
hardly comparable due to a lack of shared methodology. The Commission has begun initiatives
to arrive at more systematic agency evaluations. 4 See the principle of national institutional autonomy; Case C-8/88 Commission v. Germany
[1990] ECR I-2321. 5 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April
2004, OJ L 165. 6 Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May
1999, OJ L 136.
290 Adriaan Schout
7 See Schout 1999b in which this point is elaborated for the difference between Eurostat and
the Eurostat system. 8 Article 20.1.e from the final version of the negotiations that was agreed in December 2007
(emphasis added). 9 Article 15.1.c in the working document from November 2006. 10 Article 24 in the legislative act from December 2007 (emphasis added). 11 The Directorate for Approval and Standardisation, which has inter alia a budget for training. 12 Known as a system of ‘collective oversight’ on how operators ensure the safety of their
planes.
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